11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
UNILOC-CEMENTLESS & SELF TAP ACETABULAR
FDA 510(k)
FDA Class 3
·Orthopedic
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18425181·
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340348218·SS NON-LOCKING SCREW L18MM D5MM
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347051·SS NON-LOCKING SCREW L18MM D5MM STERILE
ZILVER 518 BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HumaPen Luxura
FDA 510(k)
FDA Class 2
·General Hospital
0002936485-2014-00379
FDA Adverse Event
Malfunction
·June 2, 2014
STYLE 163 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·November 15, 2012
DELTA CER HEAD 12/14 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code LZO·September 17, 2010
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 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