17 results · 20ms · Sources: EU EUDAMED, US FDA

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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