272 results
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36ms
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Sources: EU EUDAMED, US FDA
WISE INSTRUMENTS
FDA registration
WISE INSTRUMENTS·12 products·🇵🇰 Pakistan
WISE INSTRUMENTS INC
FDA registration
WISE INSTRUMENTS INC·12 products·🇺🇸 United States
ENDO LINEAR CUTTERS-ETS45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KOG·May 11, 2004
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Randox Laboratories, Limited·March 4, 2020
SURELOK MIS 3L
FDA Adverse Event
Malfunction
·PRECISION SPINE, INC.·Product code LXH·February 22, 2021
MAXCORE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 9, 2026
DURALOC STR CUP IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·January 12, 2017
MAXCORE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 9, 2026
MAXCORE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 9, 2026
MANUAL ORTHOPAEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code HXX·April 9, 2009
PROXIMATE I L S INTRALUMINAL STAPLER
FDA Adverse Event
Malfunction
·EES-ALBUQUERQUE·Product code GAG·January 30, 1997
ENDOPATH STEALTH ENDOSCOPIC/ CONVENTIONAL CIRCULAR STAP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY - ALB·Product code GAG·June 26, 2000
PKS CUTTING FORCEPS
FDA Adverse Event
Malfunction
·GYRUS MEDICAL INC·Product code GEI·November 2, 2010
PLICATOR
FDA Adverse Event
Injury
·NDO SURGICAL, INC.·Product code KOG·February 12, 2007
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·December 19, 2019
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NLQ·September 20, 2019
HARMONIC ACE CURVED SHEARS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 7, 2018
ENDOWRIST ONE VESSEL SEALER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·February 20, 2018
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 16, 2020