17 results · 28ms · Sources: EU EUDAMED, 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