14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREMAP ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704921031·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284881·GELPI RETRACTOR 7" WITH STOPS
CURAD COMPRESSION HOSIERY
FDA 510(k)
FDA Class 2
·General Hospital
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
FDA 510(k)
FDA Class 2
·Dental
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWP·June 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
UNK - MONO/POLYAXIAL SCREWS: VIPER 2
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·November 2, 2023
VENATECH CONVERTIBLE
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021