FDA.reportPublic FDA data

Qfix

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22479921000208827Qfix1Y2020-04-25440 CHURCH ROAD Avondale PA US 19311

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841962120319Aquaplast PS™ - "Blush, 1/16"", Trapezoidal Splint, pkg. of 10 - CSS"800-842-8688regulatory@cqmedical.com
00841962120425Opti Handle Thermoplastic Adapter - RT-4546-05+1 712-737-8688regulatory@cqmedical.com
00841962120562Fibreplast - Fibreplast Open View, Open Neck Hd+Shldr S-Frame, 3.2mm, Variable Perf with Integrated Shim8008428688regulatory@cqmedical.com
10841962107447Aquaplast PS™ - "Blush, 1/16"" Tie Down Dressings, 6"" x 9"" sheet"+1(610)268-0585Compliance@qfix.com
10841962108307VacQfix™ - VacQfix Cushion, 40cm x 79cm, 15L fill+1(610)268-0585Compliance@qfix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
472821943041343K943871AQUAPLAST TIE DOWN DRESSINGLZM1994-09-30
472821195464046K942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITSEPP1994-07-29
472821297561240K935067AQUAPLASTIYE1994-05-26
472821071001508K193243Alta Multipurpose DeviceIYE2020-02-28
472821595831490K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeIYE2018-10-04
472821860012150K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE2017-07-11
472821486070768K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solutionIYE2016-06-14
472821583825673K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm openingIYE2015-12-04
472821956181892K120916QFIX RADIOTHERAPY CHAIRJAI2012-06-20
472821058668520K090349CLEARVUE PRONE BREAST TREATMENT TABLEIYE2009-03-09
472821645050368K060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSJAI2006-05-04
472821183636257K032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENTIYE2003-09-02
472821065691530K021124ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDERIYE2002-07-02
472821347419649
472821853150943
472821899757302
472821970300556
472822026916353

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE92020-02-28
JAI22012-06-20
LZM11994-09-30
EPP11994-07-29

PMN#

GUDID#

200 records. Showing 1-40. Next