16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE SILICONE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
D-Fine Double Diamond™ Trial Kit #08
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001762·Dental burnisher
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613153992592·Posterior Stabilized Tibial Insert
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561328·Angled Box Chisel Size 8 mm
REAMER SHAFT, MOD, TRINKLE 8.0X284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012
UNICEM HM
FDA 510(k)
FDA Class 2
·Dental
DEROYAL SURGICAL DRAPES BACKTABLE COVER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 16, 2024
PERMANENT CAUTERY SPATULA INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 24, 2013
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 16, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·August 21, 2008
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 5, 2024
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 5, 2024
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2023
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016