11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KANGAROO NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenZ HT+ 98x25 A2
FDA UDI
ARGEN CORPORATION, THE·D818122847·Dental porcelain/ceramic restoration kit
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ET/SS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EYE SURGERY STRETCHER OBS 3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 21, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 3, 2011
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code LTJ·August 14, 2008
INSPIRE HVR DUAL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTN·November 12, 2024
INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·November 18, 2022
MANTIS REDUX BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·November 27, 2019
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024