19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEMI
FDA 510(k)
FDA Class 2
·Dental
Harvard Ionoresin Fill OptiCaps A3
FDA UDI
Harvard Dental International GmbH·EHAR70712511·Resin modified glass ionomer cement for restora...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293180·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049484·K-Wires, Single diamond, round end, .035-inch (...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012863·K-Wires, Single diamond, round end, .035-inch (...
ConMed
FDA UDI
Provision·B504OM50712510·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111096358·F.O. WISC AMER STYLE SIZE 0
CONMED
FDA UDI
Conmed Corporation·20845854045975·OSCILLATOR BLADE, COATED, 19.5 X 90 X 1.37 MM (...
SNIPER, MODEL OR-3872XX SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SPARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 11, 2023
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 16, 2025
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·April 6, 2007
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·October 17, 2024
UNKNOWN_MEDICAL_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 27, 2011
PEAK FX KEY SCR COUPLING ROD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 7, 2008
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018