18 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MAXI-FLOW SUCTION SET 12 FT.
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756350075·MINOR PROCEDURE CV PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112250·SURG-I-BAND YELLOW
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373643·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373629·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373636·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Bone Screws
FDA UDI
ORTHOFIX SRL·18033509850431·SELF-DRILL CORT SCREW 150/40MM STERILE SHAFT D ...
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
RAPTOR FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 12, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 4/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·May 20, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 30, 2010
TALENT AAA
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 2, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 19, 2012
VAPR3 FOOTSWITCH *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·March 28, 2022
GALAXY G3 MINI 1.5MM X 2CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·May 20, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024