2,134 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2.0MM QFX SCREW 18MM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HRS·May 13, 2021
2.0MM QFX SCREW 12MM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HRS·August 5, 2025
Diagnostic Neurosurgical Microscope Filter
FDA classification
FDA Class 2
·Diagnostic Neurosurgical Microscope Filter
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
FDA 510(k)
FDA Class 2
·General Hospital
FFX Inc.
FDA registration
FFX Inc.·1 product·🇺🇸 United States
QFR SOLUTIONS BV
FDA registration
QFR SOLUTIONS BV·2 products·🇳🇱 Netherlands
RFX+CARE MANUFACTURING CO., LTD.
FDA registration
RFX+CARE MANUFACTURING CO., LTD.·21 products·🇨🇳 China
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
FDA Enforcement
Class II
·Terminated·Vascular Solutions, Inc.·June 27, 2018
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149499·PHENIX RASP, LORDOTIC 11MM
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149482·PHENIX RASP, LORDOTIC 10MM
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149536·PHENIX RASP, LORDOTIC 9MM
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149512·PHENIX RASP, LORDOTIC 7MM
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149529·PHENIX RASP, LORDOTIC 8MM
PHENIX
FDA UDI
SPINAL ELEMENTS·00840916149505·PHENIX RASP, LORDOTIC 12MM
Vilex Tool
FDA UDI
ORTHOPEDIATRICS CORP.·00841132177891·Orthex Small Bone Hardware Tray
ClariFix
FDA UDI
ARRINEX, INC.·00868438000258·Cryogen Canister
Easy Wrap Comfit Cuff 9"-17"
FDA UDI
Omron Healthcare, Inc.·00073796364175·Easy Wrap Comfit Blood Pressure Cuff 9" to 17"
Vilex Tool
FDA UDI
ORTHOPEDIATRICS CORP.·00841132177914·Orthex Small Bone Drill Tray
Vilex Tool
FDA UDI
ORTHOPEDIATRICS CORP.·00841132177921·Orthex Small Bone Ring Tray
ClariFix
FDA UDI
ARRINEX, INC.·00868438000234·Cryotherapy System