13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DAC-CEL DIAGNATAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743557·LEVAMED ANKLE SUPPORT SILVER IV
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023970·PADDLE SPREADER, 14MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102140·Shaver, Open 14mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020452·Neck Trial, Size 14, Lateral
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
FDA 510(k)
FDA Class 3
·Cardiovascular
DIRECTVISION CATHETER, UNCOATED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINER: MPACT FLAT PE HC LINER Ø28/B
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 3, 2022
SYRINGE S2 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 21, 2021
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 14, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 9, 2007
DCM ASCENT PRIMARY LIPPER BEARING 14MM THICK X 63/67 MM WIDE
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JWH·October 31, 2012
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018