11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nautilus
FDA 510(k)
FDA Class 2
·Radiology
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
TPRLC 133 MP TYPE1 PPS HO 17.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·May 8, 2024
TPRLC 133 T1 PPS SO 17X154MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·May 8, 2024
TPRLC XR T1 PPS 14X148MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·May 8, 2024
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 29, 2008
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 23, 2011
1.5MM TI CORTEX SCREW SELF-TAPPING 11MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQN·July 11, 2013
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·November 18, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025