12 results · 19ms · Sources: EU EUDAMED, US FDA

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Medical Diode Laser (M2)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Oticon

FDA UDI
Sbo Hearing A/S·05714464028672·OTICON MORE 1 MINIRITE T C090 DEMO

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540177292·BIPOLAR FORCEPS

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDICAL FLAT PANEL DISPLAY, ME315L

FDA 510(k)
FDA Class 2 ·Radiology

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025