18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
Starbond Easy
FDA UDI
S & S Scheftner GmbH·04260207854219·Disc,12 mm ø 98,3 mm / with edging
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191377·Patella Resection Cover Size 32
OEHLER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896023949·OEHLER FORCEPS TUNGSTEN CARBIDE SERRATED TIP
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740712·Non-Perforating Towel Clamp 4" (10cm)
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376628837·SS-TL Domino Connector, 10mm
NOBELPROCERA IPS E.MAX CROWN
FDA 510(k)
FDA Class 2
·Dental
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
FDA 510(k)
FDA Class 2
·Neurology
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
ENSEAL G2 STRAIGHT JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
AIRVO HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 15, 2015
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 26, 2015
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 19, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 19, 2015
Trevo Trak 21 Microcatheter, Catalog: 90338
FDA Enforcement
Class II
·Ongoing·Stryker Neurovascular·June 5, 2024
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013