29 results · 25ms · Sources: EU EUDAMED, 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