15 results · 6ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

FDA Enforcement
Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

FDA Enforcement
Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·March 20, 2019

Drop Arm Versamode"

FDA Enforcement
Class II ·Terminated·Gf Health Products·April 14, 2021

Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

FDA Enforcement
Class II ·Terminated·GF Health Products, Inc·December 21, 2016

Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

FDA Enforcement
Class II ·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014