13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ti-Base & Master Fix
FDA 510(k)
FDA Class 2
·Dental
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037311615·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...
HUMERIS 135
FDA UDI
FX SOLUTIONS·03701037310236·HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY PE/TA6...
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM LINK BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS·Product code GAA·July 28, 2017
19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS·Product code GAA·July 28, 2017
19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·July 23, 2017
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
0.8% RESOLVE PANEL A
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·August 28, 2008
6MM COARSE DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014