40 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Premier HpSA Flex (619096)
FDA 510(k)
FDA Class 1
·Microbiology
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2309019·Sterilisation box for MicroDrive Kit ZD/RM/CRW
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857346741·Lordotic Rasp, Size 24x30x9 mm, 10°
MEDTRADE PRODICT'S SOOTHING GEL PATCH
FDA 510(k)
FDA Class 1
·General Hospital
SOMATOM DEFINITION AS OPEN
FDA 510(k)
FDA Class 2
·Radiology
PYRENEES® Cervical Plate System
FDA UDI
VB Spine LLC·10888857241961·Translational Plate, Distractor
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 11, 2023
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 17, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·December 30, 2020
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code PIO·November 10, 2020
OMNIPOD 5 PODS
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·March 3, 2025
OBTRYX? II SYSTEM - HALO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·June 20, 2025
BD CONVENTIONAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 8, 2024
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·April 30, 2024
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 19, 2023
OBTRYX II SYSTEM - HALO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 28, 2023
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 10, 2025
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 19, 2022