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