18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK COMPACT PRO
FDA 510(k)
FDA Class 2
·Microbiology
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2340120·VITA TITANKERAMIK OPAQUE DENTINE, 3L1.5, 12 g
Capo Flow Set
FDA UDI
Schütz Dental GmbH·ESDG2340121·Capo Flow is a light-curing, flowable, radiopaq...
UNIVERSAL NEURO 3
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327520507·DOUBLE-Y PLATE
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981051532·Bone Screw, Variable, Double Lead, 4.0 x 12mm
BD MAX¿ VAGINAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·February 6, 2025
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2340122·Rotary diamond instrument
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057497·Screw - Self-Tapping - Variable - 4.0x12 mm
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2340125·Rotary diamond instrument
Insignia
FDA UDI
ALPHATEC SPINE, INC.·00190376266596·4.0mm Fixed Angle, Self Tapping Screw, Dual Lea...
FG Dental Burs
FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119312016·
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
FDA 510(k)
FDA Class 2
·Neurology
Straight Arm DDR
FDA 510(k)
FDA Class 2
·Radiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
NAVILYST MEDICAL
FDA Adverse Event
Injury
·NAVILYST MEDICAL·Product code LJT·August 31, 2011
PROLENE POLYPROPYLENEMESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 18, 2013
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024