11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENFLOW IV FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750006892·8421B NON HTD PNT
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277118240·Tibial Impactor Replacement Pad Only
EVEREST® Spinal System
FDA UDI
VB Spine LLC·10888857531543·Pedicle Marker Size Ø5.5 mm
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 25, 2011
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 31, 2019
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