17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioHorizons Tapered IM Implants
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584077825·AQ CO5 B 105, 2.4G NFM DPB ANBR ACCUQ
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513011·
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100950·DESMARRES LID RETRACTOR #0
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026490·Deaver Ret, 12 ", width 4", #6
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L182070120·18mm H x 20mm W x 70mm L XLIF Trial 12 degree L...
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE LATERAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OHIO MEDICAL
FDA Adverse Event
Other
·OHIO MEDICAL CORP·Product code KDP·June 17, 2013
ADVANTAGE SERIES 26 OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 22, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014