29 results · 24ms · Sources: EU EUDAMED, US FDA

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PHANTOM FIBER BIOFIBER SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

N/A

FDA UDI
Tyber Medical, LLC·M695M1304220·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450314661·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450410752·

Prime Medical LLC

FDA UDI
Prime Medical LLC·00850055249257·PrimePadPlus-K1-3422

Portex

FDA UDI
ICU MEDICAL, INC.·15019517070330·

LINA-BAG, MODELS LB-60, LB-100

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SURGICAL STIMULATORS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 13, 2026

INST 960-339 EGG QUICK CONNECT HANDLE

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·September 13, 2016

GOBED+

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

12FR ENDO TB FOR ENDOSCPIC PLC

FDA Adverse Event
Injury ·COVIDIEN·Product code FPD·September 30, 2014

AIR OPTIX NIGHT & DAY AQUA

FDA Adverse Event
Injury ·PT CIBA VISION BATAM·Product code LPM·June 14, 2011

ADULT INSPIRATORY HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 31, 2013

GALAXY G3 XSFT 3.5MM X 7.5CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

MICRUSFRAME10 4MM X 7.5CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

GALAXY G3 XSFT 2.5MM X 5CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

GALAXY G3 MINI 1.5MM X 2CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

FDA Enforcement
Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013