27 results · 24ms · Sources: EU EUDAMED, 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