23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORUS Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Cascade
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100219·Cascade ES16
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101063·KNAPP RETRACTOR 4-PRONG SHARP
Halyard
FDA UDI
O&M HALYARD, INC.·10680651419023·ACM,PCEMKR,SRGDRP,-,XL,14
Paxeon Remedy
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570201013·Remedy Stem Size 2 High Offset
Remedy Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053239·
Remedy
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215008109·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111902010·Orion Stem, H/O (Lateralized) - Size 2
UA-CELLULAR FOR IQ
FDA 510(k)
FDA Class 2
·Hematology
EXPLOR RADIAL HEAD PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SKYLON Stem
FDA UDI
AMPLITUDE SAS·03701089520461·
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·February 25, 2020
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·May 12, 2020
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
TENDRIL DX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 11, 2014
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR·Product code FTL·July 18, 2011
POSEY KEEPSAFE ESSENTIAL
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·June 10, 2013
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·September 11, 2019
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020