15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPREHENSIVE CONVERTIBLE GLENOID
FDA 510(k)
FDA Class 2
·Orthopedic
COMP LK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925011960·JORDAN PICK 90 DEGREE TIP ANGLE, DOWN .70 MM TI...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780024750·Integra® Jarit® Russian Tissue Forceps, 5-7/8",...
ArgenZ HT+ 98x25 ML A3B
FDA UDI
ARGEN CORPORATION, THE·D818130390·Dental porcelain/ceramic restoration kit
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585068·Apex Tibial Nail Ø 13 x 390mm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981176082·Z-Rod, Dia. 6.0mm, Titanium, 390mm
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
SURGIMAX/ SURGIMAX PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·May 24, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 20, 2008
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
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