16 results
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27ms
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Sources: EU EUDAMED, US FDA
VENOJECT II BLOOD COLLECTION TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Instruments
FDA UDI
Nuvasive, Inc.·00887517385130·ALGI Curette, Down Facing Large
AcQCross Qx Integrated Transseptal Dilator/Needle
FDA UDI
ACUTUS MEDICAL, INC.·00850027837611·
FlexCath Cross™ Transseptal Solution
FDA UDI
MEDTRONIC, INC.·00763000925161·NDL 900309 FLEXCATH CROSS SL 81CM EIFU
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022643·ASSY ORTHOS A/P SGL -4LFM -10X22 LR
FlexCath Cross Transseptal Solution
FDA UDI
ACUTUS MEDICAL, INC.·00850027837925·FlexCath Cross Transseptal Solution– SL 81cm
PRATT CRYPT HOOK
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896020245·PRATT CRYPT HOOK NARROW END
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471189214·Comfort Hook™ First Molar Weldable Convertible ...
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019930826·TLIF Sizer 9mm x 24mm
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051068·.022/051 U6R TBT/HK
LAGIS ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 27, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 7, 2013
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 16, 2010
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