12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoreLink F3D Lateral System
FDA 510(k)
FDA Class 2
·Orthopedic
K883239
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009
IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPD DISP DISCONNECT, UV FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 17, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 28, 2011
PROXIMAL FEMORAL NAIL ANTIROTATION Ø10 130° L240 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDS·June 21, 2013
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 31, 2018
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" x 21 " (1) SHEET ARTRHOSCOPY "T" W/POUCH STD SMS (1) SUTURE BAG FLORAL (3) ABSORBENT TOWEL 15" X 20" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
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