39 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481123412·LOCATOR F-Tx Abutment for Narrow Neck Crossfit ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481123627·LOCATOR R-Tx Attachment System, Straumann Tissu...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128424·LOCATOR R-Tx Abutment, Straumann Tissue Level, ...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105030·Implant Inserter, 8-10mm, Sleeveless
AMIGO WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDART 520 COOLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
TITAN INFLATABLE PENILE PROSTHESIS FAMILY
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·October 20, 2021
TITAN OTR
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·February 7, 2023
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·April 3, 2013
ACRYSOF RESTOR
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·March 18, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
ALTIS SINGLE INCISION SLING SYSTEM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code PAH·May 12, 2021
ARIS TRANSOBTURATOR KIT
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code OTN·May 11, 2021
TITAN TOUCH
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·July 13, 2021
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 3, 2017