9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE PROPHYLAXIS ANGLE
FDA 510(k)
FDA Class 1
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156050·K-WIRE - SINGLE TROCAR 1.1mm DIA x 230mm
NANOBONE / GRANULATE
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX TRIMIT FAMILY
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 22, 2010
RECAP PF HA FMRL HD RESUR 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2014
HLS SET ADVANCED 7.0
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·January 11, 2021
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