13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORIGEN REINFORCED DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136025520·7450 EXSMALL W/HG MGC MADPT
SR IVOCRON
FDA 510(k)
FDA Class 2
·Dental
CARA
FDA 510(k)
FDA Class 2
·Radiology
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 6, 2023
MONGOOSE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017
NEXGEN PROVISIONAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 8, 2013
DYMO LABEL/WRITER SE 300
FDA Adverse Event
Malfunction
·DYMO·Product code ILQ·May 18, 2011
VANGUARD MONO FINNED STM TIB 71X14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·December 9, 2024
VANGUARD ROCC TIB BRG UHMWPE 60X10MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024