11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Y-Cable Top/Bottom Array 1.5T PH
FDA UDI
Noras MRI products GmbH·04251269202568·
Y-Cable Top/Bottom Array 1.5T PH
FDA UDI
Noras MRI products GmbH·04251269205927·
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007240·3813 HTD PNT 35OD, SIL P-TAPS
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2013
STRYKER ARTHROSCOPIC SHAVER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HRX·May 26, 2011
OUTLOOK 100
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FRN·August 13, 2008
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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