16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Blood Pressure Cuff Guard
FDA 510(k)
FDA Class 2
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131286529·H160V2 TI, MINIRITE 312 WL CNB AGXO
Tibial Tray Insert Shim 7.5 mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073770·
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
FDA 510(k)
FDA Class 2
·Orthopedic
SAS FLUALERT A&B, SAS INFLUENZA A TEST
FDA 510(k)
FDA Class 2
·Microbiology
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·September 13, 2013
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 3, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 28, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2022
OPEN SPINE CLAMP, TITANIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 30, 2019
MAQUET SAS
FDA Adverse Event
Malfunction
·MAQUET S.A.S·Product code FSY·May 1, 2013
POWER PRO IT AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·June 10, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTRICS CORP·Product code LTI·September 3, 2008
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020
MYAIRVO HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 6, 2016
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026