12 results · 22ms · 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.

LAMINOPLASTY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MALLINCKRODT

FDA Adverse Event
Injury ·COVIDIEN·Product code BTR·February 26, 2014

C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570

FDA 510(k)
FDA Class 2 ·Physical Medicine

BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

FDA 510(k)
FDA Class 2 ·Neurology

VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

VKMO 78000 #QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2023

HLM TUBING SET W/SOFTLINE COATING

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 2, 2013

22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code HIH·September 15, 2014

HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024