12 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MANAN GENERAL PURPOSE INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591011208·Tri-Panel Knee Immobilizer, 24"
VARIAX
FDA UDI
Stryker GmbH·07613327005882·Clav Tray 2 Level
SIGMA
FDA UDI
DEPUY (IRELAND)·10603295223481·SIGMA FEMORAL CRUCIATE RETAINING POROCOAT SIZE ...
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WHEELCHAIR MECHANICAL
FDA 510(k)
FDA Class 1
·Physical Medicine
Gibralt Spine System
FDA UDI
Choice Spine, LP·00840996169844·GIBRALT,DRILL,ADUSTABLE,2.4
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 1, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 28, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020