9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PSL TOTAL HIP REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
K-Systems
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120291·Assisted Reproduction Accessories
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEO PS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDO GIA ROTICULATOR 45-2.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US·Product code GDW·January 14, 2013
ONE STEP BUTTON¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KGC·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
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