112 results
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21ms
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Sources: EU EUDAMED, US FDA
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Synergy Disc
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Synergy Disc
Waxed Dental Floss
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063756656·Waxed Dental Floss, unflavored, 12 yds - sample...
Vivid ZirDisc Wieland System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500281·98mmx22mm SHT (Super Translucent)
SPACELABS HEALTHCARE
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122675·10 ELECTRODE PT.CABLE, SHORT.PI
ELMED
FDA UDI
ELMED INCORPORATED·00842180136939·ADAPTER FOR ELECTRODE HANDLE FOR CONNECTING MON...
ELMED
FDA UDI
ELMED INCORPORATED·00842180136922·PISTOL GRIP SUCTION/IRRIGATION HANDLE ONLY
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Anti Snore Mouthpiece
FDA 510(k)
FDA Class 2
·Dental
Widex
FDA UDI
Widex A/S·05706069898125·WIDEX EVOKE E-CIC (Clay brown ) 100, Left, RC coil
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
Aortic Stent
FDA Pre-Market Approval
FDA Class 3
·CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·COBAS TAQMAN HBV TEST
G-ARMOR COVERED STENT
FDA Adverse Event
Malfunction
·NUMED, INC.·Product code PNF·January 17, 2023
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 13, 2008
MCA LARGE APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·September 15, 2011
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code OTP·July 24, 2013
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·ROCHE COBAS TAQMAN HBV TESTS