16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAVRIC SL
FDA 510(k)
FDA Class 2
·Radiology
Nautilus
FDA UDI
Life Spine, Inc.·00190837075880·Small Compressor
SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00887661182876·
MONOSYN VIOLET 4/0 (1,5) 70 HR26 (M).
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·April 28, 2014
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
LIFTLOC SAFETY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
GALILEO NEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 15, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 3, 2011
RATCHETING SCREWDRIVER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HXX·January 30, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021