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

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Cranial 4Pi Immobilization

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM

NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KIT

FDA Adverse Event
Malfunction ·MISONIX, INC.·Product code LFL·November 21, 2024

JDENTALCARE Implant System

FDA 510(k)
FDA Class 2 ·Dental

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KIT

FDA Adverse Event
Malfunction ·MISONIX, INC.·Product code LFL·November 21, 2024

1823260-2018-00453

FDA Adverse Event
Malfunction ·February 15, 2018

NEVER TOUCH VENACURE

FDA Adverse Event
Malfunction ·ANGIODYNAMICS, INC.·Product code GEX·November 21, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 11, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026