29 results · 23ms · Sources: EU EUDAMED, US FDA

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Z-CAD smile

FDA 510(k)
FDA Class 2 ·Dental

RUSCH

FDA UDI
TELEFLEX INCORPORATED·04026704319534·SLICK SET CUFFED STERILE

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690190073·+1mm tibial recut block

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889981168698·CORTICAL SHANK, Cannulated, 7.0 X 50

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889987168692·CORTICAL SHANK, Cannulated, 7.0 X 50

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws

Ø3.5mm x 50mm Precontoured Cervical Rods

FDA UDI
XENCO MEDICAL LLC·B064XM21700501·

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Enforcement
Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

Ø3.5mm X 50mm PRECONTOURED CERVICAL RODS

FDA UDI
XENCO MEDICAL LLC·B064XMPH21700502·

R & D SYSTEMS XERET HEMATOLOGY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

VITALITY HIP SYSTEM MODEL#420

FDA 510(k)
FDA Class 2 ·Orthopedic

0 POLYSORB ENDOSTITCH

FDA Adverse Event
Injury ·COVIDIEN·Product code OCW·October 8, 2020

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

25 GA POSTERIOR WIDE-FIELD ELITE PACK

FDA Adverse Event
Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 14, 2013

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 13, 2011

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 30, 2017