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