15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
UCEZ - STERILE LENS FOG REDUCTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Waste Container D512 REF 905-590
FDA UDI
Radiometer Medical ApS·05700699055903·D512 Disposable waste container 600mL for ABL7XX
DANEK SACRAL HOOK
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABL 700/ABL 800FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·May 14, 2009
ABL 700/ABL 800FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·May 14, 2009
ABL 700/ABL 800FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·May 14, 2009
ABL 700/ABL 800FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·May 14, 2009
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 28, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010
OSS REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·January 12, 2023
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·April 16, 2009
BMET ARCOM AP PAT W/WIRE 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·February 16, 2021
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019