11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
FDA 510(k)
FDA Class 2
·Orthopedic
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020354·Keyhole Bracket
MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 16, 2008
C-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 24, 2020
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 11, 2023