17 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEMINI 16
FDA 510(k)
FDA Class 2
·Radiology
AOS CANCELLOUS LAG SCREW 4.0mm x 36mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009521·
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024403550·
ihcDirect® E-Cadherin Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596627·Clone R1005
ihcDirect® E-Cadherin Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596917·Clone R1005
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420320360·Anterio Lateral Wedge Osteotomy Guide, 32mm x 36mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410320360·Anterior Closing Wedge Osteotomy Guide, 32mm x ...
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
FDA 510(k)
FDA Class 2
·Cardiovascular
SIEMENS VIRTUAL SIMULATION (VSIM)
FDA 510(k)
FDA Class 2
·Radiology
ACUFIX/THINLINE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWQ·November 11, 2005
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·September 5, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 21, 2008
AUTOLOG IQ
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code CAC·November 10, 2025
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
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024