51 results · 23ms · Sources: EU EUDAMED, US FDA

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TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Bernafon

FDA UDI
Bernafon AG·05711584052419·JU7 CIC, BE JUNA 7

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052887·Crile Hemostatic Forceps 1x2 te...

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

K-WIRE, RECON 3.2X400 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·August 24, 2017

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·August 24, 2017

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 3, 2014

LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 31, 2013

VISX EXCIMER LASER

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code LZS·June 15, 2011

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·May 31, 2017

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·March 30, 2017

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·July 27, 2017

ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LIT·November 16, 2016

ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LIT·October 25, 2017

ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·November 27, 2018