19 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Metallic Locking Bone Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
PureLife Dental
FDA UDI
PURELIFE, LLC·D79011430021·Clear/Blue Saliva Ejectors, Phthalates-free, Fl...
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169639584·TRIAL 2143002 OLIF25 PLATE TRIAL LARGE
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506072857·ELLIK EVACUATOR ADAPTER FOR CONNECTING TOOMEY S...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776300159·Connector with clear tube for connecting Toomey...
LEONE SPA
FDA UDI
LEONE SPA·08033707011606·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 2
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·August 9, 2016
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
VERITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·May 30, 2013
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014
BD MINIDRAW¿ FINGER SLEEVE, SMALL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·August 6, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·July 25, 2016
PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014