12 results
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18ms
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Sources: EU EUDAMED, US FDA
FOX EYE ALUMINUM SHIELD, OPHTHALMIC
FDA 510(k)
FDA Class 1
·Ophthalmic
VARIAX
FDA UDI
Stryker GmbH·07613327129564·Wrist Fusion Screw Rack T10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117339·Modular Knee Stem Pilot 9mm x 150mm
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203214·Interbody, 9mm x 40mm x 9mm, 15 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195229·Interbody, 9mm x 40mm x 9mm, 15 deg
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
FDA 510(k)
FDA Class 2
·Immunology
PRIME ZOOM STRETCHER
FDA 510(k)
FDA Class 2
·Physical Medicine
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 1, 2013
ULTRA CART
FDA Adverse Event
Malfunction
·JACO·Product code LNX·December 22, 2010
TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 17, 2014
PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 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
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