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