10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TriVerse X-Ray Digital Template, PS Femur
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215115760·
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
GEMENI AST-LTS REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·January 6, 2011
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 22, 2014
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024