12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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