14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMUNOCARD C. DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
Marker Pin Grooved
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068622·
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242241·Torsional Rod Reducer (Right)
ATRAUMATIC VASCULAR CLAMPS
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 8, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
OT VERIO TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
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