18 results · 21ms · Sources: EU EUDAMED, 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