Block, Bite
Neurology · 21 CFR 882.5070
Recent MDR events
69 adverse event reports on file
- NEURAGEN, UNKNOWNNov 23, 2022MalfunctionIntegra Lifesciences Corporation1121308-2022-00109
- NEURAGEN, UNKNOWNOct 26, 2022InjuryIntegra Lifesciences Corporation Oh/usa1121308-2022-00104
- NEURAGEN 3D NERVE GUIDE MATRIX 7MM X 3CMJul 25, 2022MalfunctionIntegra Lifesciences Corporation1121308-2022-00086
- BITE GARD MOLAR BITE BLOCKDec 13, 2017MalfunctionTeleflex Medical7112203
- ENDO TUBE FIXATION DEVICE - BITE BLOCKOct 29, 2015InjuryIpi Medical ProductsMW5057678
- HUDSON BITE-GARD ORAL BITE BLOCK,INTLSep 9, 2015MalfunctionTeleflex Medical3004365956-2015-00277
- HUDSON BITE-GARD MOLAR BITE BLOCKMar 27, 2015MalfunctionTeleflex Medical3004365956-2015-00107
- MOUTH PROP - BLACK, LRG SCHEINFeb 20, 2015OtherIntegra York Pa Inc2523190-2015-00009
- BITE BLOCK - MAXI - LATEX FREE STRAPFeb 6, 2015United States Endoscopy Group, Inc.1528319-2015-00002
- BITE BLOCK - MAXISep 26, 2014MalfunctionUnited States Endoscopy Group, Inc.1528319-2014-00018
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
Teleflex Medical Llc
Morrisville, NC, US
Neurovice
Charlotte, NC, US
Gf Health Products, Inc
Atlanta, GA, US
Somatics, Llc
VENICE, FL, US
Sunmed Ap, Ltd., Warehouse No. 2
ZHUHAI Guangdong, CN
Yangjiang Junchang Trading Co., Ltd
YANGJIANG Guangdong, CN
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Sigmastim Domestic Llc
Tualatin, OR, US
Molded Devices, Inc.
Tempe, AZ, US
Sion Biotext Mexico, S.a.p.i. De C.v
Jiutepec Morelos, MX
Sunmed Ap, Ltd.
ZHUHAI Guangdong, CN
Sion Biotext Mexico, S.a.p.i. De C.v.,
Civac Mexico, MX
Allied Medical Llc
Earth City, MO, US
Yangdong Honghai Plastics Production Company
Yangjiang City Guangdong, CN
510(k) clearances
28 clearances for this product code
- Neurovice, LLCFeb 22, 2023
K221469 · PATI (Protector Against Tongue Injury)
- Mecta CorporationJun 4, 2021
K201309 · ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
- Surgovations, LLCDec 22, 2017
K172978 · SurgeoBite
- Dupaco, Inc.Jun 29, 2015
K150518 · Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
- Episafe Medical Devices, Ltd.Apr 27, 2005
K050188 · EPIGUARD
- Somatics, Inc.Oct 25, 1999
K992269 · VENTIL-A ORAL PROTECTOR
- B&B Medical Technologies, Inc.May 17, 1996
K960663 · UNIVERSAL BITE BLOCK
- United States Endoscopy Group, Inc.Jan 25, 1996
K954352 · BITE BLOCK