16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NASOSTAT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100552·KIT, NAR-4 CHEST POUCH w' COMBAT GAUZE - COY
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809811·Power Adapter, 20cc BD
ACUMED
FDA UDI
Acumed LLC·10806378040351·Mini Ratchet Handle with A/O Connection
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
FDA 510(k)
FDA Class 2
·Anesthesiology
HARDYDISK TICARILLIN 75MCG
FDA 510(k)
FDA Class 2
·Microbiology
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
BIOMET SPLINED KNEE STEM V2 15X160
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 21, 2021
BIOMET SPLINED KNEE STEM V2 15X120
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 21, 2021
VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X10 LL/R
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 21, 2021
BIOMET 360 TIBIAL SM CRUCIATE WING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 21, 2021
VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X5 RL/LM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 21, 2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018