10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITALOCK SPIKED ACETABULAR SHELL
FDA 510(k)
FDA Class 2
·Orthopedic
PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019
SKOUT system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M.U.S.T. Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013
HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 9, 2013
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 23, 2014
THINLINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 10, 2011
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