29 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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