Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3006773453
Manufacturer Name: Sybron Implant Solutions Gmbh
Manufacturer address line 1: Julius Bamberger Str 8a
Manufacturer address line 2:
Manufacturer City: Bremen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76D--YJ
Importers product description: 791118094366/ORTHODONTIC SCREWS
Refusal date: 10-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4034006-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3002808168
Manufacturer Name: Strite Industries Limited
Manufacturer address line 1: 298 Shepherd Avenue
Manufacturer address line 2:
Manufacturer City: Cambridge
Manufacturer Province/state: Ontario
Manufacturer Country: Canada
Product code: 76D--ZC
Importers product description: 945455303678 Arch Wire
Refusal date: 30-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2603121-2/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76D--ZN
Importers product description: LE CRON
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/3/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--AX
Importers product description: MIRROR HANDLE
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/1/2/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3006759928
Manufacturer Name: Stinger Manufacturing Corp
Manufacturer address line 1: 12157 W Linebaugh Ave
Manufacturer address line 2:
Manufacturer City: Tampa
Manufacturer Province/state: FL
Manufacturer Country: United States
Product code: 76E--EG
Importers product description: TEETH WHITENING LIGHT
Refusal date: 10-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: UPS-1701914-0/1/1/
Carrier: UNITED PARCEL SERVICE OF CANA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3004500587
Manufacturer Name: Supermercados Mayoristas Yagua
Manufacturer address line 1: Crisologo Larralde Y Acceso Tigre 1648
Manufacturer address line 2:
Manufacturer City: Pcia De Bsas
Manufacturer Province/state:
Manufacturer Country: Argentina
Product code: 76E--FW
Importers product description: DENTAL BRUSH
Refusal date: 09-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: BFV-0163316-3/2/1/
Carrier: EVERGREEN LINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3005040705
Manufacturer Name: Ninbo Ninghai China Source Foreign Trade
Manufacturer address line 1: 803
Manufacturer address line 2:
Manufacturer City: Ninghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 76E--FW
Importers product description: HEALTH CARE TOOTHBRUSH 6 PK ASSTD
Refusal date: 09-SEP-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: KG2-0525030-4/5/1/
Carrier: EVERGREEN LINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3003933220
Manufacturer Name: Pacific Direct S R O
Manufacturer address line 1: Podlesi 53
Manufacturer address line 2:
Manufacturer City: Holice
Manufacturer Province/state:
Manufacturer Country: Czech Republic
Product code: 76E--FW
Importers product description: TOOTHBRUSH, MANUAL
Refusal date: 18-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 416-0105201-6/1/1/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007108382
Manufacturer Name: Sense Dental Lobro
Manufacturer address line 1: 1f 10 Lane 27 Sec
Manufacturer address line 2:
Manufacturer City: Taipei
Manufacturer Province/state:
Manufacturer Country: Taiwan
Product code: 76E--HY
Importers product description: 856400724208/TEETH STONE MODEL
Refusal date: 15-SEP-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-4322122-6/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3005382447
Manufacturer Name: Gtech Dental Lab.
Manufacturer address line 1: 57 Sampaguita St.
Manufacturer address line 2:
Manufacturer City: Marikina
Manufacturer Province/state:
Manufacturer Country: Philippines
Product code: 76E--IH
Importers product description: 644395101345/DENTURE CERAMIC FUSED TO BA
Refusal date: 19-SEP-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-4481869-9/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3006610063
Manufacturer Name: Fkg Dentaire Sa
Manufacturer address line 1: Cret Du Locle 4
Manufacturer address line 2:
Manufacturer City: Le Cret Du Lo
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 76E--JB
Importers product description: 863558021221/DENTAL HANDLE (FILE)
Refusal date: 25-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2397876-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--JE
Importers product description: FINGER COVER
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/6/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--KJ
Importers product description: BURNISHERS
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/1/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007068773
Manufacturer Name: Rajab & Silsilah
Manufacturer address line 1: P O Box
Manufacturer address line 2:
Manufacturer City: Jeddah
Manufacturer Province/state:
Manufacturer Country: Saudi Arabia
Product code: 76E--MA
Importers product description: 865353797952/BONE CEMENT
Refusal date: 11-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3972716-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MG
Importers product description: FORCEPS
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/2/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MI
Importers product description: BONE FILES
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/5/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MJ
Importers product description: ROOT ELEVATOR
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/2/4/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3007055806
Manufacturer Name: Aaaz Instruments
Manufacturer address line 1: Mughal Pura Post Office Pur Town
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MN
Importers product description: SCALER
Refusal date: 23-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9127967-5/1/1/
Carrier: EMIRATES AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
DEVICEGMPS
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: K-FILES, CC+, STERILE
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: FLEXICUT-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: HEDSTROEM-FILESM CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: GATES-ENLARGERS, C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/4/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: M2 BASIC SEQ, 4X,
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/5/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: HEDSTROEM-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: GATES-ENLARGE C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: PEESO-ENLARGERS C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: K-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/4/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL 2 IN 1 KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL DOWN PACK KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: C-PILOT FILES, CC+ STERILE
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/4/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006175698
Manufacturer Name: Invivo Germany Gmbh
Manufacturer address line 1: Haus3
Manufacturer address line 2:
Manufacturer City: Schwerin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76K--LE
Importers product description: Tumor localizer "LeLoc" device, unknown product code
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3905754-3/1/3/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006175698
Manufacturer Name: Invivo Germany Gmbh
Manufacturer address line 1: Haus3
Manufacturer address line 2:
Manufacturer City: Schwerin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76K--LE
Importers product description: Tumor localizer "LeLoc" device, unknown product code
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3905754-3/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006808276
Manufacturer Name: Shenghua International Co Ltd
Manufacturer address line 1: Unit D 16/F Cheuk Nang 21 Century Pl
Manufacturer address line 2:
Manufacturer City: Hong Kong
Manufacturer Province/state:
Manufacturer Country: China
Product code: 76M--CF
Importers product description: LED LAMPS
Refusal date: 17-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: BYV-0083418-0/1/1/
Carrier: WAN HAI LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED