11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Avantik VTM
FDA 510(k)
FDA Class 1
·Microbiology
KASM KNEE ARTICULATING SPACER MOLDS
FDA 510(k)
FDA Class 2
·Orthopedic
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
FDA 510(k)
FDA Class 1
·Dental
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·September 2, 2011
BELT CLIP PUMP CLEAR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 18, 2013
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·AOMORI OLYMPUS CO., LTD.·Product code GEI·November 11, 2022
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
FDA Enforcement
Class I
·Terminated·Focus Diagnostics Inc·April 13, 2016
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
FDA Enforcement
Class II
·Terminated·Focus Diagnostics Inc·April 13, 2016
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
FDA Enforcement
Class I
·Terminated·Focus Diagnostics Inc·April 13, 2016
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021