12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HIVOX BIOTEK INC.
FDA 510(k)
FDA Class 2
·Neurology
MICROFUSE PUTTY AND MICROFUSE ST MIS
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 15, 2022
PRIME ZOOM STRETCHER,30"LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·May 14, 2013
ORBIT GALAXY DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·September 23, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011
FLEXI SEAL SIGNAL (FMS)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code KNT·October 11, 2016
CARDIOSAVE HYBRID
FDA Adverse Event
Injury
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021