15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SpheRx
FDA UDI
Nuvasive, Inc.·00887517442703·SpheRx® II Conn, 40-45mm Adj Transverse
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·00678467508263·Esophageal 4 Channel Catheter
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467507843·24-Channel Customized Single-Use Esophageal Cat...
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467507775·24-Channel Customized Single-Use Anorectal Cath...
VARELISA MPO ANCA, MODEL 17648/17696
FDA 510(k)
FDA Class 2
·Immunology
Bioflux Software II
FDA 510(k)
FDA Class 2
·Cardiovascular
JGRLOC B2B RD TI SLD DRL KIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·September 17, 2019
PINN LNR CON +4 NEUT 32IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC·Product code KWZ·November 19, 2008
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 17, 2011
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
JGRLOC B2B RD TI SLD DRL KIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·June 6, 2019
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
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