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

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INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NAMILON POWDER

FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI200420690·NAMILON POWDER 16 OZ SHADE 69

C & B FORMULA

FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400420690·C & B FORMULA 1 LB SHADE 69

ASCEND SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

FDA 510(k)
FDA Class 2 ·Neurology

PASS LP

FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

ATLANTIS, FIXED SCREWS

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWQ·April 5, 2013

LAMITRODE 44 SURGICAL LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 31, 2011

ENDOTAK ENDURANCE EZ

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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