16 results · 20ms · Sources: EU EUDAMED, US FDA

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gammaCore Sapphire

FDA 510(k)
FDA Class 2 ·Neurology

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465449·CDH HA COATED MAS 8.5X30

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741918300·

CHUCK HANDLE

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075207·CHUCK HANDLE ROUND

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180543627·30mm Cervical Tooth Blade, Wide

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674191830060·

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZMACHINE, MODEL DT-100

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

ACCENT DR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 26, 2013

IDRIVE POWERED HANDLE

FDA Adverse Event
Malfunction ·UNITED STATES SURGICAL·Product code GDW·July 29, 2011

Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.

FDA Enforcement
Class II ·Terminated·ASO, LLC·August 14, 2013

Neusoft NeuViz 64 Multi-slice CT Scanner System

FDA Recall
Terminated ·Neusoft Medical System Co·Product code JAK·March 8, 2014

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024