14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAUS SUS10
FDA 510(k)
FDA Class 2
·Dental
HHM
FDA UDI
Oticon A/S·05707131279958·H160, DESIGNRITE 10 WL CRED HHM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
Spacelabs Healthcare
FDA UDI
Statcorp Medical·10841522104657·BP CUFF,TL NYLON,1T,LG.ADULT-LONG,35-44CM,HP,EA
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
STINGRAY EPIDURAL CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHOVITA PEEK SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® K2 EDTA 2.0ML BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·February 2, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 21, 2022
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
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