16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES ACIS/VERTEBRAL SPACER CR
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 100x12
FDA UDI
ARGEN CORPORATION, THE·D818120275·Dental porcelain/ceramic restoration kit
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007386·SOSOFT 8-15 MM HG KNEE HIGH RIB EXTRA LARGE SAN...
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476712·
SI-LUTION Sacroiliac Joint Fusion System
FDA UDI
CURITEVA, INC.·B648C6151202750·3.2 X 275mm SHARP GUIDE PIN
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 7, 2011
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·October 1, 2018
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