20 results
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19ms
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Sources: EU EUDAMED, US FDA
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
FDA 510(k)
FDA Class 2
·Anesthesiology
Instruments
FDA UDI
Nuvasive, Inc.·00887517385185·ALGI Curette, Up Angled Small
Tibial Spacer
FDA UDI
ADLER ORTHO SPA·08052693626823·14 mm LB TIBIAL SPACER
ReLine
FDA UDI
Nuvasive, Inc.·00195377068224·RELINE C Conn,3.5-4/3.5-4mm Top-Top
MAXBRAID
FDA UDI
TELEFLEX INCORPORATED·34026704582762·Blue braided Size 2 K-61 N White braided 2 K-61...
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028135·3M™ Unitek™ Stainless Steel First Permanent Mol...
MAXBRAID
FDA UDI
TELEFLEX INCORPORATED·14026704582768·Blue braided Size 2 K-61 N White braided 2 K-61...
TELEFLEX
FDA UDI
TELEFLEX INCORPORATED·64026704582763·Blue braided Size 2 K-61 N White braided 2 K-61...
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471163146·018 L/R SW NONCONV 7
SMALL UP-ANGLED CURETTE
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code LXH·September 1, 2023
INCENTIVE SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
FDA 510(k)
FDA Class 2
·Neurology
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019923323·TLIF Sizer 14mm x 24mm
SMR GLENOID PEG TT SMALL-R #M
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·October 17, 2019
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 16, 2010
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·December 21, 2012
SMR GLENOID PEG TT SMALL-R #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·October 5, 2020
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