17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tek RMD (Tek Robotic Mobilization Device)
FDA 510(k)
FDA Class 2
·Physical Medicine
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029342·PESSARY, RING #4, W/KNOB AND W/SUPPORT, 2.75"
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Injury
·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013
TORNIER
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HXX·June 22, 2011
MONOCRYL (POLIGLECAPRONE 25) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAN·September 4, 2008
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012