13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LANX SPINOUS PROCESS FUSION PLATE
FDA Adverse Event
Injury
·LANX, INC.·Product code KWP·March 17, 2011
LEONE SPA
FDA UDI
LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028152·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776362959·Oral Elevator, #46, Right,
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·February 26, 2014
MAGNUM
FDA 510(k)
FDA Class 2
·Physical Medicine
INSIGHT 4000 ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 15, 2014
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·April 19, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024