17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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