13 results · 19ms · Sources: EU EUDAMED, US FDA

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GM60A-32S & GM60A-40S

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131286024·NERA2 PRO TI, RITE 312 WL SIL

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690111573·Modular Stem 9mm x 75mm

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100011·BARRAQUER WIRE SPECULUM LARGE WITH TABS

TECHNO-SCOPE VISUAL STETHOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

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

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Enforcement
Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 7, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

4.5MM CORTEX SCREW SELF-TAPPING 34MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HWC·April 17, 2013

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Recall
Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025