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