25 results · 20ms · Sources: EU EUDAMED, 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