12 results
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19ms
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Sources: EU EUDAMED, US FDA
MEDICAL LCD MONITOR
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MININEPH HUMAN RHEUMATOID FACTOR KIT
FDA 510(k)
FDA Class 2
·Immunology
ORTHOSIS,PEDICLE SPINAL FIXATION
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·December 8, 2015
BDRV CANN SCW SS P/T DIA4.5X60 MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017
BDRV CANN SCW SS P/T DIA4.5X52 MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 25, 2015
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
FDA Recall
Terminated
·Epimed International, Inc.·Product code BSP·April 22, 2016
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015