4,036 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Disposable Hybrid Trocar System (23 gauge/ 0.6 mm) (27 gauge/ 0.4mm)
FDA UDI
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872018904·
Hand Driver for Harmony/Mono Implants
FDA UDI
ETGAR - MEDICAL INSTRUMENTS LTD·07290112447494·Hand Driver for Harmony/Mono Implants
UNKNOWN MEDIUM PRESSURE FLOW CONTROL VALVE
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·April 3, 2013
SYNCHROMED 2
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LKK·July 17, 2009
NEUROBLATE SYSTEM
FDA Adverse Event
Injury
·MONTERIS MEDICAL·Product code GEX·June 18, 2021
INTELLIVUE MX400 PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 5, 2018
21 GAUGE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·April 22, 2024
HEARTMATE 2
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·April 10, 2019
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013
DURAGEN 4X5 1 PACK CE
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·July 17, 2024
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
FDA Recall
Terminated
·Synvasive Technology Inc·Product code HSD·March 14, 2013
CATHETER IV AUTOGUARD 20 GA
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD·Product code FOZ·January 16, 2018
CAVITRON SELECT W/RESERVOIR G123
FDA Adverse Event
Malfunction
·DENTSPLY LLC·Product code ELC·March 3, 2023
ALARIS PUMP MODULE
FDA Adverse Event
Death
·CAREFUSION·Product code FRN·July 5, 2019
COVIDEN SHILEY ENDOTRACEAL TUBE
FDA Adverse Event
Injury
·MEDTRONIC (COVIDEN) / COVIDIEN·Product code BTO·November 12, 2021
BD EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·April 15, 2025
4.0MM OPEN CONNECTOR CLOSURE TOP
FDA Adverse Event
Injury
·Product code KWP·December 1, 2015
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·November 8, 2012
MEDSYSTEM III
FDA Adverse Event
CAREFUSION·Product code FRN·October 29, 2012
CAVITRON 300 SERIES G310SCLR(DNA)
FDA Adverse Event
Malfunction
·DENTSPLY LLC·Product code ELC·April 28, 2025