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