16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
FDA 510(k)
FDA Class 2
·Radiology
Altus Spine Pedicle Screw System
FDA UDI
Altus Spine, LLC·00843210132303·Pedicle Tap, Dual Lead
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 55mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025286·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609232·SKYTRON 4.25" SOFTCARE PLUS
J. MORITA USA, INC.
FDA registration
J. MORITA USA, INC.·13 products·🇺🇸 United States
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 4300 PSARRAY EEG ELECTRODE SET
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 30, 2023
STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 26, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTORNIC NEUROMODULATION·Product code LKK·April 14, 2011
HUTPLUS FINAL ASSY, REV-RIGHT
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·July 21, 2008
AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 25, 2022
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 20, 2023
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 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