15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Cordelle II Sound Processor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Oticon
FDA UDI
Oticon A/S·05707131281982·H15V2, MINIBTE 312 WL 85 CBE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100165·KRATZ-BARRAQUER SPECULUM SMALL
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
Symmetry Surgical Ultra®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482055649·Ultra Instruments Clamp; Bulldog Artery Clamp; ...
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162088·BABY TISCHLER PUNCH, 8", 2MMX4MM BITE, TIP UP, ...
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
FDA 510(k)
FDA Class 2
·Radiology
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 13, 2025
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962111178·BULLDOG ARTERY CLAMP, 2", CVD, TITANIUM
TRULIANT TIB IMP PS INSERT SZ 5 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 4, 2024
FIBERED IDC OCCLUSION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·June 6, 2013
SPECTRA OPTIA EXCHANGE SET
FDA Adverse Event
Injury
·CARIDIANBCT·Product code LKN·June 29, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015