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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TENS STIMULATOR, MODELS 2800 AND 3000

FDA 510(k)
FDA Class 2 ·Neurology

RHEAD

FDA UDI
Stryker GmbH·00886385024059·Stem Implant 6mm Collar,Size 1

ALL SILICONE FOLEY BALLOON CATHETER

FDA UDI
Sewoon Medical Co., Ltd.·08806369402507·2way/Translucent 30cc 14fr

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193108094·HA PEEK EVOS Straight, ,14mmx8mmx 30mm , FLAT ...

CRYOPEN CRYOSURGICAL SYSTEM, K102214

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450191286·

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

V200 / ESPRIT

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 7, 2021

V200 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 9, 2020

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 21, 2021

NORIAN REINFORCED FAST SET PUTTY/3CC

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013

BIOSTEON WEDGE INTERFERENCE SCREW

FDA Adverse Event
Malfunction ·BIOCOMPOSITES LTD.·Product code HWC·May 20, 2011

HYDRATOME RX SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FDI·August 7, 2008

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