15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
FDA 510(k)
FDA Class 2
·Ophthalmic
EasyWinch 20 mm
FDA UDI
G21 SRL·08058964727596·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746095405·DB BRACKET MASTER SERIES MAND BICUSPID 020X020 ...
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·October 8, 2012
CORTEK MINI LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JIAJIAN ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
LOCK SELF-CENTERING HEAD Ø47
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·September 19, 2022
CEMENTED GLENOID 3 PEGS SMALL
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code KWS·June 16, 2023
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 26, 2013
EVOLVE
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH, INC.·Product code IKY·May 2, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 7, 2013
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 10, 2010
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Enforcement
Class II
·Ongoing·Scientia Vascular, Inc.·March 22, 2023
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015