17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028246·PESSARY, DONUT #4, 3"
EPIDUCER LEAD DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AQUADEX SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·September 8, 2015
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
SonarMed AirWave Monitor, Model Number M0001
FDA Enforcement
Class II
·Terminated·SonarMed Inc·September 11, 2019
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·August 10, 2016
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023