25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PELVIC MUSCLE THERAPY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Varisoft™
FDA UDI
Unomedical A/S·05705244018785·Single use infusion set for subcutaneous infusi...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040054809·Strip Crown Forms
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009399·PedFuse Reset, CNL, 9.0mm x 30mm
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 13, 2014
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 20, 2020
UNKNOWN 0 DEGREE ALUMINA INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 13, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·February 28, 2011
COVIDIEN/KENDALL
FDA Adverse Event
Malfunction
·COVIDIEN·Product code LZH·February 21, 2008
VariSoft infusion set, Model Number 1002830
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 12, 2014
EZ-IO 25MM NEEDLE + STABILIZER BX/5 (NO)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·June 10, 2021
VariSoft infusion set, Model Number 1002830
FDA Enforcement
Class I
·Ongoing·Unomedical A/S·November 29, 2023
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·January 7, 2016
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·October 8, 2014
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016