9 results
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18ms
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Sources: EU EUDAMED, US FDA
LINEAR ENZMATIC URIC ACID SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GE Healthcare
FDA UDI
SHENZHEN LAUNCH ELECTRICAL CO., LTD·06947437900340·ECG 3 Lead Cable Undetachable, Grabber, AHA, 4....
Rad-Sure™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065383·Blood Irradiation Indicator
IS-1 HEMOSTASIS VALVE, MODEL 6799
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVOKNEE TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·December 17, 2007
PROPAQ CS 246
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DRT·October 11, 2012
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