21 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUANTUM DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
InnoSpire Deluxe
FDA UDI
VEGA TECHNOLOGIES INC.·06946159502023·1112279
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242739·Universal Joint Driver, Hex Size 15
PATTON TRIPOL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INCU I
FDA 510(k)
FDA Class 2
·General Hospital
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
150 MICRON TFL BALL TIP SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEX·March 26, 2022
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 29, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
NO COMBINATION PENDANT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 29, 2011
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
BD¿ 10 ML DISPOSABLE STERILE SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 21, 2017
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024
10ML BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 29, 2017
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021
BD DISCARDIT II¿ SYRINGE W/NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 28, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021