14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OCCLUSION BALLOON CATHETER, MODEL VENOS
FDA 510(k)
FDA Class 2
·Cardiovascular
CD66c-PE
FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934134074·REA414 recognizes the human CD66c antigen, a gl...
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 7, 2023
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·April 9, 2014
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 30, 2023
KARL STORZ
FDA Adverse Event
Other
·Product code FCL·April 4, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 14, 2011
PER-Q-CATH PLUS SILICONE CVC
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·July 18, 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