18 results
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26ms
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Sources: EU EUDAMED, US FDA
BICARBONATE REAGENTS PRODUCT #7713 & #7714
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978078922·DISTRACTOR 900-420 14X6X8MM FIXED
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587833·Apex Femoral Nail Retrograde Ø 9.0 x 420mm
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981129279·Tissue Retractor
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584481·Apex Tibial Nail Ø 9.0 x 420mm
CURE LP
FDA UDI
SpineArt SA·07640332475287·VARIABLE DRILL GUIDE
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B167900420000·
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117601·
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
FDA 510(k)
FDA Class 2
·General Hospital
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
FDA 510(k)
FDA Class 2
·Neurology
FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·November 23, 2020
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 7, 2013
VISISTAT SKIN STAPLER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·October 27, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 6, 2014
DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·September 14, 2020
DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·February 2, 2021
STEALTHSTATION S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 13, 2021
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