8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELMED ESU 300 M/M AND DIGITAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
Traus SSG30 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
TRIDENT 32 0 DEGREE LINER
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·December 14, 2010
FLOTATION CUSHION
FDA Adverse Event
Malfunction
·UNKNOWN·Product code KIC·July 14, 2014
BASIC CONFIGURATION MODEL 6100 BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 28, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013