13 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KINEX BIOACTIVE
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378556·Integra® Jarit® Russian Tissue Forceps, 7-3/4",...
ArgenZ HT+ 98x25 ML A4B
FDA UDI
ARGEN CORPORATION, THE·D818130392·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925011984·JORDAN PICK 45 DEGREE TIP ANGLE, UP, SLIM .70 M...
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SAPPHIRE DETACHABLE COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
COMP LK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2013
SYSTEM 5 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 9, 2011
SAGB QUICK CLOSE
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL·Product code LTI·August 20, 2008
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016