13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NC Straumann Screw Retained Abutments
FDA 510(k)
FDA Class 2
·Dental
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095621311·Pipette tip,1000-5000uL,natural for Biohit and ...
CRANIAL REMOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
SONOTIP II ULTRASOUND NEEDLE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HANDLE-SM MINI-QUICK-COUPL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 6, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014