119 results
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29ms
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Sources: EU EUDAMED, US FDA
HEALTHPAK X-RAY SOX BARRIERS
FDA 510(k)
FDA Class 2
·Dental
75H - PG&E Class B 21 BBP
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233079·PG&E Class B 21 BBP - 75H
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NUVASIVE NVM5 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 22, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 13, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016
PROTAPER H-U ASS.21MM *NOT CE*
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·April 1, 2026
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 29, 2025
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·May 16, 2024
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 21, 2021
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 6, 2025
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·September 15, 2023
GUIDE WIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 25, 2025
RADIFOCUS GUIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·December 5, 2023
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 3, 2018
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 23, 2026