15 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPOSIX
FDA UDI
Davol Inc.·00801741031175·Composix E/X Mesh, 10" x 14" (25.4 cm x 35.6 cm...
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138125124·PREMIUM ABDOMINAL BINDER 9IN XLG (46-62)
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331143885·barron knife handle, #3, octagonal, for blades ...
OSSPRAY SYLC CR
FDA 510(k)
FDA Class 1
·Dental
LUMEND FRONTRUNNER CTO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PEN NDL 29GA 12.7MM 100 BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 25, 2025
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·May 21, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
MESA PEDICLE SCREW
FDA Adverse Event
Injury
·K2M, INC·Product code MNI·September 5, 2008
ARCHITECT B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025
Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 17, 2022
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025