27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ScrewPlus® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105619·3.7mmD x 10mmL, 4.7mmD Platform
RIGIDFIX
FDA UDI
Medos International Sàrl·10886705003044·RIGIDFIX Femoral Rod 10mm, 30-120mm (Plus or Mi...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED
Liofilchem MIC Test Strip (MTS)
FDA UDI
LIOFILCHEM SRL·08055182870028·MIC Test Strip is a quantitative assay for dete...
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
UNITOX BOTOX SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2025
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·November 17, 2006
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021