24 results · 34ms · Sources: EU EUDAMED, US FDA

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GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001049·artVeneer life upper anteriors, IS, A2

JBC

FDA UDI
FOREMOUNT ENTERPRISE CO., LTD.·04719871892268·Bacterial Viral Filter

TruFlex™

FDA UDI
Ortho Organizers, Inc.·00190707126834·TRUFLEX NiTi Thermal Upper 20x20 (10pk)

TruFlex

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015082·NiTi Thermal Upper 20x20 10 archwires per pack

TheraFlo Cover 60'' × 80'' QLT Sen-1p

FDA UDI
Tridien Medical·00841965103944·TheraFlo Cover 60'' × 80'' QLT Sen-1p

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20010490·2.4mm Cannulated Screw, Self Drilling, Short Th...

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE

FDA 510(k)
FDA Class 2 ·Dental

SUNI MAX

FDA 510(k)
FDA Class 1 ·Dental

MultiPolar®

FDA UDI
Zimmer, Inc.·00889024115415·

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Injury ·DEXCOM INC.·Product code MDS·March 13, 2013

UNKNOWN ZIMMER MIS TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code JWH·February 21, 2011

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code MUZ·February 22, 2008

ACRYSOF SINGLEPIECE IOL

FDA Adverse Event
Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·July 30, 2024

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

CABLE-READY CERCLAGE CABLES

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KTT·October 20, 2017

Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.

FDA Enforcement
Class II ·Terminated·Greatbatch Medical·June 8, 2016

Xhibit Telemetry Receiver, Model: 96280

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014