17 results · 31ms · Sources: EU EUDAMED, 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