14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERFECTA PLASMA SPRAY HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Reusable Instruments used with SOVEREIGN® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994320643·TRIAL 7964218 S 32X23 18MM 12 DEG
Empower Tube
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746198304·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-20 R...
Empower Tube
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746201967·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-20 R...
Empower SL Molar
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746030925·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-20 R...
Empower SL Molar
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746030932·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-25 R...
Empower Tube
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746201974·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-25 R...
Empower Tube
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746197796·DB TUBE SL EMPOWER LL 1ST MOL 018/018AUX T-25 R...
SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROCON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEX 60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 15, 2013
WORKHORSE II PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQY·December 22, 2010
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 29, 2014
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