12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032917·Baltic Denture System BDLoad ↓ Sw7 PLSEum6DFs B...
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
20 DEG ANGLE DRIVER
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBE·March 29, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 29, 2011
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·April 23, 2008
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024