11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P200DTx
FDA 510(k)
FDA Class 2
·Ophthalmic
Equator
FDA UDI
Preat Corporation·00842092180006·Equator Abutment for Astra EV 3.0 x 7mm
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOSIS,PEDICLE SPINAL FIXATION
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·December 8, 2015
FLAT SILICONE DRAIN
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, INC.·Product code GBX·May 22, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
TRIDENT 0 DEG CONSTRAINED INSERT 22D
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWZ·June 22, 2011
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 25, 2015
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022