9 results
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18ms
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Sources: EU EUDAMED, US FDA
CARAFLEX ELASTIC POLYMER PLASTER BANDA
FDA 510(k)
FDA Class 1
·Physical Medicine
Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668120187·McPherson Straight Bi-Polar Forceps
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTOCO2L INSUFFLATOR MODEL 6400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RUSCH 2 WAY SILICONE CATHETER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·March 31, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
POSEY NON SKID SLIPPERS
FDA Adverse Event
Malfunction
·DONGGUAN POSEY MEDICAL DEVICE LTD.·Product code IKX·August 18, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
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