12 results · 21ms · Sources: EU EUDAMED, US FDA

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PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

FDA 510(k)
FDA Class 2 ·Dental

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040009376·Zirlux 16+ P2 coloring liquid

N/A

FDA UDI
Smith & Nephew, Inc.·00885554000931·TRAY W/LID INTF SCREW SYS

UCLA AND UNIVERSAL ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)

FDA 510(k)
FDA Class 1 ·General Hospital

STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·May 26, 2025

PROFEMUR(R) MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·March 19, 2013

CHILLI II ABLATION CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code LPB·March 9, 2011

KINETRA

FDA Adverse Event
Malfunction ·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code MHY·March 10, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018