14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
FDA 510(k)
FDA Unclassified
·Unknown
Silicone Flat Drain
FDA UDI
C. R. Bard, Inc.·00801741090738·Hubless Silicone Flat Drain, 7mm Wide, 20cm Lon...
Cordant
FDA UDI
Seaspine Orthopedics Corporation·10889981115319·Plate - 3 Level - 60mm (07-0360)
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742111513·LYNX ø4.0mm Cancellous Screw, Full Thread, Ti -...
ABR-2000
FDA 510(k)
FDA Class 2
·Neurology
RX G-UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON·Product code OTN·April 22, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·June 30, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 18, 2011
SILICONE FLAT DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·September 23, 2025
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019