Data / Medical devices / Canada / Can Technomed Trading Ltd.
Can Technomed Trading Ltd.: FDA-registered device maker in Richmond British Columbia, Canada, 133 510(k) clearances and 5 PMA approvals
Can Technomed Trading Ltd. is registered with the FDA (registration 3015276088) in Richmond British Columbia, Canada. It lists 31 device types. The FDA files 133 510(k) clearances and 5 PMA approvals under its listings, the newest dated July 11, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015276088
- Address
- 1025-11111 Twigg Pl., Richmond British Columbia, Canada, V6V 0B7
- Owner or operator
- Can Technomed Trading LTD. (10059827)
- Roles
- Exporter to the US
- First device listed
- February 27, 2019
- Registered through
- 2027
- Brand names listed
- 1.5T 12 CHANNEL BODY ARRAY, 1.5t 16 channel brain-spine array coil, 123, ACHIEVA 1.5T, ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES, ALLURACLARITY XPER FD SERIES X-RAY SYSTEM, Achieva 1.5 Tesla MR System, Achieva MR System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 133.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2025 | K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 3, 2025 | K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241898 | Symbia SPECT and SPECT/CT Systems | KPS | Substantially Equivalent | Siemens Healthineers | accessdata.fda.gov |
| March 26, 2024 | K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 30, 2023 | K232155 | syngo.CT Dual Energy | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 2, 2023 | K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 16, 2023 | K230421 | SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 13, 2022 | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | IYN | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. | accessdata.fda.gov |
| August 23, 2022 | K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| April 27, 2022 | K212441 | Philips Incisive CT | JAK | Substantially Equivalent | Philips Healthcare (Suzhou) Co., Ltd. | accessdata.fda.gov |
| February 4, 2022 | K213938 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| January 13, 2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 23, 2021 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| December 1, 2021 | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | MOS | Substantially Equivalent | Philips Healthcare (Suzhou) Co., Ltd. | accessdata.fda.gov |
| September 24, 2021 | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| June 12, 2020 | K193166 | MAMMOMAT Revelation | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 10, 2020 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 12, 2019 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | JAK | Substantially Equivalent | Canon Medical Systems Corporation | accessdata.fda.gov |
| June 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 15, 2019 | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 17, 2018 | K181767 | Cios Select | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 15, 2018 | K181407 | Artis zee/zeego & Artis Q/Q.zen | OWB | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| May 14, 2018 | K173576 | Pristina Serena | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 4, 2018 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 21, 2018 | K173408 | Mammomat Revelation | MUE | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| November 9, 2017 | K171850 | Philips CT Big Bore | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| October 6, 2017 | K172406 | Ingenuity TF | KPS | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| March 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 6, 2017 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 16, 2016 | K163213 | Revolution CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| November 29, 2016 | K163066 | TxRx Knee 15 Flare MR Coil 3.0T | MOS | Substantially Equivalent | Quality Electrodynamics, LLC | accessdata.fda.gov |
| September 8, 2016 | K162337 | Symbia 6.5 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 8, 2016 | K160743 | Philips Ingenuity CT | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| November 24, 2015 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 12, 2015 | K151752 | SOMATOM Emotion 6/16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 29, 2015 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 18, 2015 | K151028 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 8, 2015 | K143400 | SOMATOM Definition AS/AS+ | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 22, 2014 | K141065 | CONSTELLATION VISION SYSTEM | HQE | Substantially Equivalent | Alcon Research, Ltd. | accessdata.fda.gov |
| August 21, 2014 | K142006 | SYMBIA 6.0 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 31, 2014 | K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| July 10, 2014 | K133819 | VERADIUS | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 30, 2014 | K133189 | DUAL SHOT ALPHA 7 | DXT | Substantially Equivalent | Nemoto Kyorindo Co., Ltd. | accessdata.fda.gov |
| June 26, 2014 | K141454 | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | LMC | Substantially Equivalent | Sony Electronics, Inc. | accessdata.fda.gov |
| May 15, 2014 | K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | KGI | Substantially Equivalent | Ge Medical Systems Ultrasound & Primary Care Diagn | accessdata.fda.gov |
| May 1, 2014 | K132027 | OEC 9800 PLUS | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| March 28, 2014 | K133174 | ORTHOSCAN FD MINI C-ARM | OXO | Substantially Equivalent | Orthoscan, Inc. | accessdata.fda.gov |
| December 13, 2013 | K130704 | MICRODOSE SI | MUE | Substantially Equivalent | Philips Digital Mammography Sweden AB | accessdata.fda.gov |
| September 24, 2013 | K131773 | BRILLIANCE ICT | JAK | Substantially Equivalent | Philips Healthcare (Cleveland) | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 16, 2013 | K131634 | SYMBIA | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 28, 2013 | K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 11, 2013 | K123520 | MAMMOMAT INSPIRATION PRIME | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 21, 2013 | K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | IZI | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 17, 2013 | K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| February 22, 2013 | K122286 | MAMMOMAL INSPIRATION | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 8, 2013 | K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| December 13, 2012 | K123492 | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) | MOS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 10, 2012 | K112989 | AQUILION CXL | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| April 6, 2012 | K120710 | AQUILION PRIME | JAK | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| April 6, 2012 | K120613 | OEC 9900 ELITE | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| February 14, 2012 | K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| October 4, 2011 | K111551 | OEC(R) 9800, OEC(R) 9800 PLUS | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| September 19, 2011 | K111912 | MOBILETT MIRA | IZL | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 16, 2011 | K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 28, 2011 | K110025 | SECTRA MICRODOSE MAMMOGRAPHY | MUE | Substantially Equivalent | Sectra Imtec AB | accessdata.fda.gov |
| March 4, 2011 | K103127 | SOMATOM DEFINITION AS | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 11, 2011 | K103275 | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 17, 2010 | K092564 | O-ARM IMAGING SYSTEM | OXO | Substantially Equivalent | Medtronic Navigation, Inc. (Littleton) | accessdata.fda.gov |
| April 6, 2010 | K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM | IZH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| December 10, 2009 | K093514 | DISCOVERY MODEL NM/CT 670 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| June 30, 2009 | K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | IZL | Substantially Equivalent | Shimadzu Corp. | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 25, 2008 | K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | MOS | Substantially Equivalent | Quality Electrodynamics | accessdata.fda.gov |
| September 2, 2008 | K082104 | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| May 9, 2008 | K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 7, 2008 | K073592 | OPTISTAR ELITE INJECTION SYSTEM | DXT | Substantially Equivalent | Mallinckrodt Inc., Liebel-Flarsheim Business | accessdata.fda.gov |
| April 11, 2008 | K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | KPS | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| March 28, 2008 | K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | KGI | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| March 14, 2008 | K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| October 2, 2007 | K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| April 27, 2007 | K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | IZQ | Substantially Equivalent | Mallinckrodt Inc., Liebel-Flarsheim Business | accessdata.fda.gov |
| January 4, 2007 | K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 | LNH | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| October 13, 2006 | K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| June 5, 2006 | K060937 | BRILLIANCE VOLUME | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| May 5, 2006 | K060758 | OR HEAD COIL 1.5 T | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052581 | LUNAR IDXA | KGI | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Dia | accessdata.fda.gov |
| October 12, 2005 | K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | MOS | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| October 7, 2005 | K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| October 7, 2005 | K052584 | 1.5T 12 CHANNEL BODY ARRAY | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| September 27, 2005 | K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 21, 2015 | P140011 | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | OTE | 8 | July 1, 2026 | accessdata.fda.gov |
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
| August 20, 2004 | P030010 | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | 6 | November 5, 2010 | accessdata.fda.gov |
| March 15, 2002 | P010025 | LORAD DIGITAL BREAST IMAGER | MUE | 17 | November 16, 2010 | accessdata.fda.gov |
| January 28, 2000 | P990066 | GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | 36 | November 5, 2010 | accessdata.fda.gov |
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Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.