14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
InnoSpire Essence
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730001944·Innospire Essence Assembly 230v 50hz (UK)
JETSTREAM XC
FDA UDI
Bayer Healthcare LLC·00616258005157·JETSTREAM XC 2.4MM, FG PKG
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006212·2600MPL 2W T MED MPORT SALIVA
JETSTREAM™ XC
FDA UDI
BOSTON SCIENTIFIC CORPORATION·08714729889922·Atherectomy Catheter
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·September 24, 2018
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG,·Product code NVZ·May 24, 2011
DEKA SMARTXIDE² TRIO
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023
THRUWAY¿
FDA Adverse Event
Malfunction
·LAKE REGION MEDICAL·Product code DQX·October 1, 2024
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