12 results · 18ms · 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.

THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT

FDA 510(k)
FDA Class 2 ·Hematology

2.4MM LOCKING RECON SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036059330·

Shoreline ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981177591·12mm, 2-Hole Threaded Anterior Plate

Sklar®

FDA UDI
SKLAR CORPORATION·10649111204593·GUYON SOUNDS W/O THREAD 12FR

ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™

FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118116817·Intramedullary fixation screw

Half Dome Posterior Lumbar Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

Armada™ 14 NC PTA Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

2.4MM X 12MM HT X-DRIVE LOCKING RECON SCREW

FDA Adverse Event
Other ·BIOMET MICROFIXATION, INC.·Product code HWC·December 19, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 5, 2014

ENDOSTAT ELECTROSURGICAL UNIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 4, 2010

RECEPTAL CANISTER 1000 ML CE

FDA Adverse Event
Malfunction ·AMSINO MEDICAL CO., LTD.·Product code GCX·November 15, 2012

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022