27 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
FDA 510(k)
FDA Class 2
·Ophthalmic
SCHROEDER VULSELLUM BONE REDUCTION CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051171·SCHROEDER VULSELLUM BONE REDUCTION CLAMP WITH S...
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971185·
AMSINO MEDICAL USA
FDA Adverse Event
Other
·AMSINO MEDICAL USA·Product code FOZ·May 20, 2009
GELCLAIR CONCENTRATED ORAL GEL
FDA 510(k)
FDA Unclassified
·Unknown
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DREAMSTATION
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 14, 2025
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·May 9, 2013
TALENT TAA
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·September 19, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·PLASTI ESTERIL, S.A. DE C.V.·Product code FKX·May 25, 2011
ARCOS LATERAL TROCH BOLT 42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 22, 2017
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 14, 2018
Infant Warmer System (IWS)
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 18, 2017
Infant Warmer System (IWS)
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023