8 results
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17ms
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Sources: EU EUDAMED, US FDA
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT
FDA 510(k)
FDA Class 1
·General Hospital
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HOOK KNIFE 4MM & 5MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 15, 2014
TRIATHLON PS FEM COMPONENT CEMENTED
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·October 24, 2012
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·June 15, 2015
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
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