12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011845026000·dentaform® Bands Central Upper right No. 26
NA
FDA UDI
Zimmer, Inc.·00889024102309·
AMETHERM
FDA 510(k)
FDA Class 2
·General Hospital
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024074453·
NA
FDA UDI
Zimmer, Inc.·00889024074477·
NA
FDA UDI
Zimmer, Inc.·00889024074460·
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014
CURLIN INFUSION 6000 PAINSMART IOD IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·October 24, 2012
SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·September 27, 2010
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006