FDA.reportPublic FDA data

ADAPTIVE SWITCH LABORATORIES, INC.

Matched from indexed company URL: Adapt Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16451431000118602ADAPTIVE SWITCH LABORATORIES, INC.1N2026-01-01125 SPUR 191, SUITE C SPICEWOOD TX US 78669
30087724213008772421ADAPTA MEDICAL, INC.1N2026-01-01142 Talamine Ct Colorado Springs CO US 80907
30098794263009879426ADAPTIVE BIOTECHNOLOGIES1N2026-01-0119910 N Creek Parkway S Bothell WA US 98011
30114456093011445609ADAPTIVE IMPORTS LLC1Y2026-01-012760 Circleport Dr Erlanger KY US 41018
30136827043013682704ADAPTIVE SENSORY TECHNOLOGY INC1N2026-01-019823 Pacific Heights Blvd Suite CD San Diego CA US 92121
30140180423014018042ADAPTIX LIMITED1N2026-01-01Adaptix Ltd, Centre for Innovation & Enterprise Oxford University Begbroke Science Park Oxford Oxfordshire GB OX5 1PF
30148732363014873236ADAPTIIV MEDICAL TECHNOLOGIES, INC.1N2026-01-011559 Barrington Street Suite 200-D Halifax Nova Scotia CA B3J 1Z8
30165003423016500342AdaptDx, Inc1N2026-01-011000 Kreider Drive, STE 700 Middletown PA US 17057
30198955513019895551ADAPTIVE BIOTECHNOLOGIES1N2026-01-011165 Eastlake Avenue East Seattle WA US 98109
30095094093009509409ADAPTIVE ENGINEERING LAB, INC.1N2020-04-25102 E Keefe Ave Milwaukee WI US 53212
30095274833009527483ADAPTIVE ENERGY, LLC1N2020-04-255500 S STATE RD Ann Arbor MI US 48108
30142710013014271001ADAPTEC MEDICAL DEVICES LLC1N2020-04-25260 James Jackson Avenue Cary NC US 27513

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
00860007402340TrueFlex Bolus - TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.+1 (902) 442-9091suport@adaptiiv.com
00860007402371Nova Surface Applicator - Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Rate (HDR) brachytherapy by providing a patient-specific fit and catheter trajectory design. The applicator is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, and radiation therapists. It is only intended to be utilized in radiation therapy, where a patient requires a total prescription dose on or near the skin surface. The device is made of methacrylic resin.+1 (902) 442-9091support@adaptiiv.com
00860007402388TrueFit Bolus - TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).+1 (902) 442-9091support@adaptiiv.com
05061068070003Adaptix Ortho350 - The Adaptix Ortho350 (K252133) is a 3D tomographic X-ray device intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device comprises of an Ortho350 C-Arm Assembly and a Control PC. It is also possible to create 2D X-ray images of the desired anatomy.The Adaptix Ortho350 device is a portable system that can be placed on a benchtop or the floor or mounted on an optional cart for added mobility. To obtain 3D tomosynthesis images, the relevant area of the patient is positioned against the detector cover then X-rays are emitted from a controlled sequence of locations. The system uses a low-power, monoblock X-ray source with integrated controls and feedback, synchronized electronically with the detector for tomosynthesis image acquisition. The system is operated by an X-ray technologist or suitably qualified healthcare professional using and designed with safety features to only allow X-ray emission when multiple controls are in place.+441865634406support.ortho@adaptix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3438591238074077K252133Adaptix Ortho350IZF2025-11-06
2220881276434936K243057TrueFit Bolus; TrueFlex BolusMUJ2024-10-23
2220881141708221K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)MUJ2024-08-30
2220881070950576K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy AccessoryMUJ2022-01-19
3235931444009941K200009Adaptive Biotechnologies clonoSEQ AssayQDC2020-08-05
2268511444009941K200009Adaptive Biotechnologies clonoSEQ AssayQDC2020-08-05
2220881716258974K1802893D Bolus SoftwareMUJ2018-07-10
1220712063366980K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CEZD2016-08-16
3235931694775542DEN170080Adaptive Biotechnologies clonoSEQ AssayQDC2018-09-28
2268511694775542DEN170080Adaptive Biotechnologies clonoSEQ AssayQDC2018-09-28
2366441244504113
130241477886997
2458021530384362
1395351931714895
2074911960376652
2268511477680726
3426121513034992
2074911629690979
2074911916169522
130241921246434

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUJ42024-10-23
QDC42020-08-05
IZF12025-11-06
EZD12016-08-16

NDC#

Oxygen

AdaptHealth West, LLC

Oxygen

PMN#

NAVIGATOR I

2003-11-13

ADAPTIVE HEALTHCARE TECHNOLOGIES, INC.

Applications#

GUDID#

Adaptix Ortho350 - The Adaptix Ortho350 (K252133) is a 3D tomographic X-ray device intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device comprises of an Ortho350 C-Arm Assembly and a Control PC. It is also possible to create 2D X-ray images of the desired anatomy.The Adaptix Ortho350 device is a portable system that can be placed on a benchtop or the floor or mounted on an optional cart for added mobility. To obtain 3D tomosynthesis images, the relevant area of the patient is positioned against the detector cover then X-rays are emitted from a controlled sequence of locations. The system uses a low-power, monoblock X-ray source with integrated controls and feedback, synchronized electronically with the detector for tomosynthesis image acquisition. The system is operated by an X-ray technologist or suitably qualified healthcare professional using and designed with safety features to only allow X-ray emission when multiple controls are in place.

ADAPTIX LIMITED

2025-11-19

TrueFit Bolus - TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).

Adaptiiv Medical Technologies Inc

2024-12-09

TrueFlex Bolus - TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.

Adaptiiv Medical Technologies Inc

2024-12-09

Nova Surface Applicator - Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Rate (HDR) brachytherapy by providing a patient-specific fit and catheter trajectory design. The applicator is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, and radiation therapists. It is only intended to be utilized in radiation therapy, where a patient requires a total prescription dose on or near the skin surface. The device is made of methacrylic resin.

Adaptiiv Medical Technologies Inc

2024-12-09

TrueFit Bolus - TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).

Adaptiiv Medical Technologies Inc

2024-12-09

Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) - Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.

Adaptiiv Medical Technologies Inc

2022-08-16

Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) - Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.

Adaptiiv Medical Technologies Inc

2022-08-16