10 results
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27ms
·
Sources: EU EUDAMED, US FDA
OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GC Initial™
FDA UDI
Gc America Inc.·J0228740081·GC Initial™ Ti Powder Opaque OB3, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704643·GC Initial™ IQ/ Layering-over-Zircon Body A, 250g
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109175·CORBIN SUB-TENONS CANNULA 23GA
PENLON AM1000 ANAESTHESIA MACHINE
FDA 510(k)
FDA Class 2
·Anesthesiology
SABOURAUD DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 5, 2014
PUMP MMT-554WWP PRDGM INS PL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 15, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·December 14, 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