112 results · 21ms · Sources: EU EUDAMED, US FDA

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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