13 results
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23ms
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Sources: EU EUDAMED, US FDA
ALM OPERATING TABLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403152634·Snowden-Pencer DIAMOND-TIP OSTEOTOMES PARKES 18...
Ormco
FDA UDI
ORMCO CORPORATION·00889989014044·LUG BICUSPID LOOSE EA
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884019220·dentaform® Band, Tooth 46, Size 19/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884019180·dentaform® Band, Tooth 46, Size 19/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884019000·dentaform® Band, Tooth 46, Size 19
BIGGY AGAR NICKERSON MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
STREP ID TRIPLATE
FDA 510(k)
FDA Class 1
·Microbiology
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 19, 2014
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·RICE CREEK MFG·Product code DTB·December 21, 2012
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·October 14, 2010
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
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014