19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
FDA 510(k)
FDA Class 2
·Physical Medicine
PMMA disc
FDA UDI
Dentsply International Inc.·D00180713200·
Conmed/Linvatec
FDA UDI
Provision·B504OM50713200·
Conmed/Linvatec
FDA UDI
Provision·00810041065926·
INTREX
FDA UDI
Conmed Corporation·10845854011003·INTREX LARGE BONE OSCILLATING SAW BLADE 25.0 X ...
NA
FDA UDI
STERILMED, INC.·10888551020633·SAW BLADE SAGITTAL
Matira Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07307K0173200·Assembly, Driver Shaft, T-Handle, Locking Cam
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
NOBELACTIVE INTERNAL RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
FDA 510(k)
FDA Class 2
·Orthopedic
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
DLT TS CER HD 12/14 40MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code LZO·April 13, 2011
HAKIM V-C 60CM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC/MEDOS S.A.·Product code JXG·July 8, 2008
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
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 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