29 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIMPLYGO BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ILIZAROV SYSTEMS
FDA UDI
MEDICALPLASTIC SRL·28033201841963·WASHER SLOTTED
restor3d Total Talus Replacement
FDA UDI
Restor3d, Inc.·00840097509891·Impactor, Flat
LEONE SPA
FDA UDI
LEONE SPA·08033707068822·DB BRACKET TWEEZERS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702349535·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 5 C...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702559101·ELVAREX 3/CHAP STYLE/OPEN TOE/SLIP FORM WITH VO...
L1 MANDIBLE
FDA UDI
KLS-Martin L.P.·00888118142221·PULLOUT TRAY, TRANSBUCCAL
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2022
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493420394·CONSTRAINED STRAIGHT ROD, 5.5mm x 600mm
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493420691·CONSTRAINED STRAIGHT ROD, 6.0mm x 600mm
LITWIN CRUICATE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·January 21, 2025
UNKNOWN COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·July 13, 2023
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 1, 2013
NOVOPEN 4
FDA Adverse Event
Injury
·NOVO NORDISK A/S·Product code FMF·September 11, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 20, 2011
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
FDA Enforcement
Class I
·Ongoing·Nurse Assist, LLC·December 27, 2023
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025