10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
FDA 510(k)
FDA Class 2
·Neurology
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269484·
Bernafon
FDA UDI
Bernafon AG·05711584079720·AQ CO7 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331146022·brown tissue forceps, 8x8 teeth, 10" (25.0 cm)
VESSEL GUARDIAN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2013
FEMORAL IMPACTOR EXTRACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·June 23, 2011
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015