17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269453·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513127·
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18032568866070·GOTFRIED PC.C.P. NECK SCREW - 130 MM
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18033509850578·GOTFRIED PC.C.P. NECK SCREW - 130 MM STERILE
Femoral Sound
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039646·
TENZING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 25, 2016
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 25, 2026
11CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·June 14, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 23, 2011
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.
FDA Enforcement
Class II
·Terminated·Integra Limited·November 6, 2013