15 results · 21ms · Sources: EU EUDAMED, US FDA

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BriefCase-Triage

FDA 510(k)
FDA Class 2 ·Radiology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776416539·Cobb Elevator, 11", 1.25" Wide End, Round Handle

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776410483·COBB ELEVATOR 11 LONG 1.5" WIDE ROUND HANDLE

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455806·Integra® Jarit® Cobb-Type Spinal Elevator, Roun...

AngioSystems Tray

FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026557·

ORL Video NasoPharyngo-Larngoscope

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ELECTRODE

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 28, 2024

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·November 6, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 26, 2013

VERSAONE

FDA Adverse Event
Malfunction ·DAVIS & GECK CARIBE LTD·Product code GCJ·July 17, 2024

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 15, 2018

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013