17 results · 30ms · Sources: EU EUDAMED, US FDA

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AI-ECG Platform

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAESTRO TOTAL WRIST

FDA UDI
Biomet Orthopedics, LLC·00880304555198·

Maestro™ Total Wrist

FDA UDI
Biomet Orthopedics, LLC·00887868240034·

ANDREWS PYNCHON SUCTION

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000506·ANDREWS PYNCHON SUCTION STAINLESS STEEL

ANDREWS PYNCHON SUCTION

FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804320·ANDREWS PYNCHON SUCTION STAINLESS STEEL

OLYMPUS EMPOWER H65

FDA Adverse Event
Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

MAPERSOL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

FDA Adverse Event
Injury ·AESCULAP AG·Product code NKB·December 21, 2018

ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

FDA Adverse Event
Injury ·AESCULAP AG·Product code NKB·December 21, 2018

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022