FDA.reportPublic FDA data

Patient positioning foam mould kit

Definition
A collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould of that anatomy. The mould can be whole body or only selected body parts and are commonly used to help ensure adequate positioning and immobilization of the patient during radiation therapy treatments and to facilitate reproducible positioning for serial treatments.
GUDID devices
107
Last updated
2026-08-28 10:27:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628341931915InstaformCDR Systems Inc12026-08-17
00840510401436KLARITY MEDICALKlarity Medical Products, LLCR550-L32026-07-22
00841439103029AccuForm™ CushionMEDTEC, INC.MTACL142422017-08-02
00841439103036AccuForm™ CushionMEDTEC, INC.MTACL15202017-08-02
00841439103081AccuForm™ CushionMEDTEC, INC.MTACL60602017-08-02
00841439103098AccuForm™ CushionMEDTEC, INC.MTACLTYPES12017-08-02
00841439114391AccuForm™ CushionMEDTEC, INC.MTACLTYPESN2023-03-11
00840510400392KLARITY MEDICALKlarity Medical Products, LLCR550-LB42025-10-28
00840510401276KLARITY MEDICALKlarity Medical Products, LLCR550-LBS2026-05-29
00628341930321InstaformCDR Systems Inc12019-12-31
00817355027640KLARITY MEDICALKlarity Medical Products, LLCR550-PS252024-02-22
00817355027657KLARITY MEDICALKlarity Medical Products, LLCR550-PS272024-02-22
00817355027664KLARITY MEDICALKlarity Medical Products, LLCR550-PS352024-02-22
00817355027671KLARITY MEDICALKlarity Medical Products, LLCR550-PS372024-02-22
00840510400385KLARITY MEDICALKlarity Medical Products, LLCR550-LB32025-10-28
00840510401191KLARITY MEDICALKlarity Medical Products, LLCR550-HS32026-05-05
00841439113059Registration FilmMEDTEC, INC.PRO3402019-10-10
00841439113585AccuForm™ ShimMEDTEC, INC.MTACLSHIM2021-05-16
00841439114032Pediatric Registration FilmMEDTEC, INC.PRO4402022-08-20
08058045280125TOTIM Patient Cushion Immobilization SystemESSEBI MEDICAL SRLTTM3005M CERVICAL M 2020-03-06
08058045280170TOTIM Patient Cushion Immobilization SystemESSEBI MEDICAL SRLTTM3010M NECK M2020-03-06
00840510401016KLARITY MEDICALKlarity Medical Products, LLCR550-U122026-03-02
00840510400972KLARITY MEDICALKlarity Medical Products, LLCR550-L12026-02-10
00817355025523KLARITY MEDICALKlarity Medical Products, LLCR550-U82021-11-18
00817355027794KLARITY MEDICALKlarity Medical Products, LLCR550-CM32024-06-19
00840510400675KLARITY MEDICALKlarity Medical Products, LLCR550-BOS72026-01-05
00840510400538KLARITY MEDICALKlarity Medical Products, LLCR550-P32025-12-08
00840510400118KLARITY MEDICALKlarity Medical Products, LLCR550-CM62025-09-22
00817355022362KLARITY MEDICALKlarity Medical Products, LLCR550-CEL2025-09-04
00817355023888KLARITY MEDICALKlarity Medical Products, LLCR550-CSL2025-09-04
00817355024861KLARITY MEDICALKlarity Medical Products, LLCR550-P22025-09-04
00817355027503KLARITY MEDICALKlarity Medical Products, LLCR550-U12025-09-04
00817355027695KLARITY MEDICALKlarity Medical Products, LLCR550-EM12025-09-04
00840510400033KLARITY MEDICALKlarity Medical Products, LLCR550-CAEP22025-09-04
00817355027213KLARITY MEDICALKlarity Medical Products, LLCR550-CEAP22023-01-03
00840510400002KLARITY MEDICALKlarity Medical Products, LLCR550-U11T2025-08-26
00817355028173KLARITY MEDICAL Klarity Medical Products, LLCR550-BOS42025-07-15
00817355028494KLARITY MEDICAL Klarity Medical Products, LLCR550-BOS62025-07-15
00817355029682KLARITY MEDICAL Klarity Medical Products, LLCR550-BOS52025-07-15
00817355029613KLARITY MEDICALKlarity Medical Products, LLCR550-CELC22025-07-01
00817355028241KLARITY MEDICALKlarity Medical Products, LLCR550-CM42025-06-26
00817355028753KLARITY MEDICAL Klarity Medical Products, LLCR550-CM52025-06-02
00817355028760KLARITY MEDICALKlarity Medical Products, LLCR550-U4T2025-06-02
00817355028777KLARITY MEDICALKlarity Medical Products, LLCR550-U10T2025-06-02
00817355028609KLARITY MEDICALKlarity Medical Products, LLCR550-LB12025-04-25
00817355028616KLARITY MEDICALKlarity Medical Products, LLCR550-LB22025-04-25
00817355028166KLARITY MEDICALKlarity Medical Products, LLCR550-SBOS2024-11-08
00817355027961KLARITY MEDICALKlarity Medical Products, LLCR550-PS452024-07-25
00817355027978KLARITY MEDICALKlarity Medical Products, LLCR550-PS472024-07-25
00817355025660KLARITY MEDICALKlarity Medical Products, LLCR550-B32024-01-05
00817355025677KLARITY MEDICALKlarity Medical Products, LLCR550-BOS22024-01-05
10841962107331Adapt-It™QfixRT-70012016-09-13
10841962107348Adapt-It™QfixRT-70032016-09-13
00841439114407AccuForm™ CushionMEDTEC, INC.MTACLTYPES22023-03-11
00841439114414AccuForm™ CushionMEDTEC, INC.MTACL2035U2023-03-11
00841439114421AccuForm™ CushionMEDTEC, INC.MTACL5865T2023-03-11
00817355027084KLARITY MEDICALKlarity Medical Products, LLCR550-U92022-11-09
00817355027077KLARITY MEDICALKlarity Medical Products, LLCR550-K2022-11-07
00817355027060KLARITY MEDICALKlarity Medical Products, LLCR550-PS2022-11-03
00841439114049Pediatric Cushion GuideMEDTEC, INC.PRO4502022-08-20
10841439114039Pediatric Registration FilmMEDTEC, INC.PRO4402022-08-20
10841962117835Adapt-It™QfixRT-70012021-12-20
10841962117842Adapt-It™QfixRT-70032021-12-20
00817355025561KLARITY MEDICALKlarity Medical Products, LLCR550-CC22021-11-15
10841439113582AccuForm™ ShimMEDTEC, INC.MTACLSHIM2021-05-16
00817355025288KLARITY MEDICALKlarity Medical Products, LLCR550-U62021-04-26
00817355025172KLARITY MEDICALKlarity Medical Products, LLCR550-B22021-03-29
00817355024663KLARITY MEDICALKlarity Medical Products, LLCR550N-M12020-05-11
00817355024670KLARITY MEDICALKlarity Medical Products, LLCR550N-L2020-05-11
00817355024649KLARITY MEDICALKlarity Medical Products, LLCR550-CC12020-05-06
00841439113066Cushion GuideMEDTEC, INC.PRO3502019-10-10
10841439113056Registration FilmMEDTEC, INC.PRO3402019-10-10
00817355023833KLARITY MEDICALKlarity Medical Products, LLCR550-CAEP2019-02-08
00817355023840KLARITY MEDICALKlarity Medical Products, LLCR550-CAEP12019-02-08
00817355024144KLARITY MEDICALKlarity Medical Products, LLCR550-U42019-07-18
00817355024151KLARITY MEDICALKlarity Medical Products, LLCR550-U52019-07-18
00817355024175KLARITY MEDICALKlarity Medical Products, LLCR550-CELC12019-08-08
00817355024618KLARITY MEDICALKlarity Medical Products, LLCR550-U72020-04-16
00817355024489KLARITY MEDICALKlarity Medical Products, LLCR550N-L22020-03-26
00817355024496KLARITY MEDICALKlarity Medical Products, LLCR550N-U2020-03-26