13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MB 11
FDA 510(k)
FDA Class 2
·Neurology
BIOMET MAXIM MODULAR FINNED STEM 40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2017
BIOMET ARCOM PATELLA W/WIRE 34MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2017
BIOMET PRIMARY INTERLOK TIBIAL TRAY 67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2017
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 22, 2013
MESH - COMPOSIX
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·April 20, 2011
ON-Q PAINBUSTER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·July 9, 2008
CUSTOM INTERLOK TITANIUM VANGUARD PS FEMORAL LEFT 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2017
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Zeiss brand IOLMaster 500, Model 500, 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
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015