14 results
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18ms
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Sources: EU EUDAMED, US FDA
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881231220·dentaform® Snap Band, Tooth 36, Size 31/Roth 22
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308552·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308682·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308446·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881231180·dentaform® Snap Band, Tooth 36, Size 31/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881231000·dentaform® Snap Band, Tooth 36, Size 31
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308323·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DePuy Synthes T-PAL Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
OXIMAX N-600 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code DQA·October 6, 2010
BIONAIRE
FDA Adverse Event
Malfunction
·SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS·Product code KFZ·February 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 20, 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