17 results · 22ms · Sources: EU EUDAMED, US FDA

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PLEXUR-P

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5820805110·RONGEUR

iTotal® Patella Trial

FDA UDI
Conformis, Inc.·00850268007101·iTotal® 35mm Patella Trial Reusable Instrument

LEONE SPA

FDA UDI
LEONE SPA·08033707001096·STANDARD SCREWS S/STEEL 11mm UPPER

Clamp, Hysterectomy, model Z 24cm slightly curved

FDA UDI
Geister Medizintechnik GmbH·04057034373132·Clamp, Hysterectomy, model Z 24cm s...

MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS

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

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

APEX¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 26, 2013

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·July 24, 2014

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 24, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014