9 results
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17ms
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Sources: EU EUDAMED, US FDA
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SERVOMED PULSE AMPLIFIER MODULE-206-
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXCUT DIAMOND BURS (6/pk) CRS 6845-023
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006845231·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014
NCB PP DIST FE PLATE, R, 9 H, L. 238MM
FDA Adverse Event
Other
·ZIMMER GMBH·Product code HRS·November 8, 2012
SUPER POLIGRIP
FDA Adverse Event
Injury
·UNK·Product code KOL·September 22, 2010
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006
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