18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
DETACHOL
FDA UDI
FERNDALE LABORATORIES, INC.·00304960513021·ADHESIVE REMOVER
Optimotion Blue CR HCCR Total Knee System
FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0513020·CR Tibial Insert, UHMWPE + Vitamin E, Size 5, ...
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RANDOX DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ENDO LINEAR CUTTERS-ECHELON 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·April 10, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011
SAFELINT HORIZON PUMP IV SET
FDA Adverse Event
Other
·B. BRAUN OF DOMINICAN REPUBLIC·Product code FPA·May 22, 2008
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W.L. GORE & ASSOCIATES·Product code MIH·March 31, 2014
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·November 16, 2022
BLUNT TIP SCREW,4X48MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·November 18, 2022
BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·November 18, 2022
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 1, 2021
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 1, 2021
BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 3, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012