15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES USS CONNECTORS
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131234094·GET, BTE P 13 SIL
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664005559·FOR MEN CASUAL 15-20 MM HG KNEE HIGH CLOSED TOE...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116916·Trautmann Gouge, 9mm
140mm,...
1.5T 16-CHANNEL HAND-WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
HANAROSTENT BILIARY (NNN)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 9, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·August 12, 2008
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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