12 results
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50ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PALINDROME RT CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexitron
FDA UDI
Nucletron B.V.·08717213026711·Flexitron Transfer Tube for Metal Needles (11)
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRIDGE FX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 19, 2023
EXETER V40 STEM 37.5MM NO 0
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008
MLX 300W XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code FCW·October 7, 2021
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025