17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MLS, ZERONA-AD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007942·SOSOFT 30-40 MM HG KNEE HIGH BROCADE LARGE BLAC...
ARGISTAR B 75PF (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120257·Gold based noble metal
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017145·Hook Scissors 3.5mm 45 degree left
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017138·Hook Scissors 2.7mm 45 degree left
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 14, 2020
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 24, 2021
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013
ZYDERM 2 COLLAGEN IMPLANT (0.5ML)
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 7, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 14, 2008
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015