13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Preat
FDA UDI
Preat Corporation·00842092138304·Equator Abutment for Astra EV 5.4 x 3mm
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981441333·M/L Angled Rake Curette with Teeth, 23°
PIONEER CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSPECS
FDA 510(k)
FDA Class 2
·Radiology
BMT GB KNEE STM 12X40
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
SHILEY
FDA Adverse Event
Injury
·COVIDIEN·Product code JOH·May 29, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 20, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 26, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022