12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CATH CONTROL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Damon 3
FDA UDI
ORMCO CORPORATION·00889989003468·U2L DAMON 3 .022 +8/+9/0
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450816493·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142110·Trial, TLIF, 32L OB CRV 7Deg, 11mm
BIOSELF 2000 FERTILITY INDICATOR
FDA 510(k)
FDA Unclassified
·Unknown
OXYARM CO2
FDA 510(k)
FDA Class 2
·Anesthesiology
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
FDA Recall
Terminated
·Ormco Corporation·Product code DYW·November 3, 2005
HYLAMER 10D 70OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDL·December 1, 2010
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2014
RAPID RESORBABLE CRANIAL CLAMP 18MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GXR·December 7, 2012
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
FDA Recall
Terminated
·Ormco Corporation·Product code DYW·November 3, 2005
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021