12 results
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26ms
·
Sources: EU EUDAMED, US FDA
TABLE MAT MORTORIZED/ELECTRIC
FDA 510(k)
FDA Class 1
·Physical Medicine
XLIF
FDA UDI
Nuvasive, Inc.·00887517840752·XLIF Kerrison Dilator Holder, 16"
FIXOS
FDA UDI
Stryker GmbH·07613252708735·Drawer Modules
Trinias
FDA UDI
SHIMADZU CORPORATION·04540217048915·
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PFNA Ø10 LONG LE 130° L360 TAN
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code JDS·August 2, 2017
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 19, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 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