10 results
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26ms
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Sources: EU EUDAMED, US FDA
COE-SOFT LC
FDA 510(k)
FDA Class 2
·Dental
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975058942·
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665586926·MIS Cannulated Screw M, Ø10.5 x 65mm, Ø5.5mm Rod
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
FDA 510(k)
FDA Class 2
·Neurology
VARIAX 2 COMPRESSION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·January 30, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·December 21, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·July 17, 2014
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. 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
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology