8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLAMPEASE FA
FDA 510(k)
FDA Class 2
·Cardiovascular
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
THERA DR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO·Product code DXY·June 10, 2014
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·November 1, 2012
S5DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND GMBH·Product code DTQ·June 17, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
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