14 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MULTI-WASH

FDA 510(k)
FDA Class 1 ·General Hospital

ELMED

FDA UDI
ELMED INCORPORATED·00842180170797·disimpaction forceps, ROWE, right, 24,0cm, for ...

INFPUMP INFILTRATION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

QIAstat-Dx GI Panel 2 Mini B

FDA 510(k)
FDA Class 2 ·Microbiology

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 8, 2013

PLUM LC OL CNVRTBL P

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 14, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·July 22, 2014

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 8, 2013

LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

FDA Enforcement
Class I ·Terminated·Covidien·February 11, 2015

ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

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