Data / Medical devices / Netherlands / Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.: FDA-registered device maker in BEST Noord-Brabant, Netherlands, 130 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3042177665) in BEST Noord-Brabant, Netherlands. It lists 7 device types. The FDA files 130 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042177665
- Address
- Veenpluis 6, BEST Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 0.6T Marconi Wrist and Hand Array, 0.6T Panorama 4Ch Breast Array, 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil, 1.5T 16CH Cardiac Coil- Anterior, 1.5T 16CH Cardiac Coil- Posterior, 1.5T 16Ch GE Shoulder Coil, 1.5T 32CH Cardiac Coil- Anterior, 1.5T 32Ch Cardiac Coil- Anterior and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Biopsy / Localization Tray | PXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
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 130.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2026 | K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 24, 2026 | K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 20, 2026 | K260519 | Smart Fit TorsoCardiac 1.5T | MOS | Substantially Equivalent | Philips Healthcare (Suzhou) Co., Ltd. | accessdata.fda.gov |
| February 23, 2026 | K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 14, 2026 | K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| 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 |
| June 4, 2025 | K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 18, 2024 | K243033 | dS Wrist coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 18, 2024 | K242879 | dS Knee Coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 12, 2024 | K242096 | dS FootAnkle Coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 24, 2023 | K233348 | 16 Breast Coil | MOS | Substantially Equivalent | Philips Medical System Nederlands B.V. | accessdata.fda.gov |
| October 3, 2023 | K232762 | dS Breast Coil 7ch 1.5T | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| September 1, 2023 | K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | MOS | Substantially Equivalent | Philips Healthcare (Suzhou) Co., Ltd. | 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 |
| April 28, 2023 | K230972 | Ingenia Elition and MR 7700 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 6, 2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 23, 2022 | K223442 | MR 5300 and MR 7700 R11 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| August 31, 2022 | K222325 | 8ch Wrist Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | 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 |
| August 8, 2022 | K213735 | dS Sentinelle Breast 16ch 1.5T Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| August 8, 2022 | K213727 | dS Sentinelle Breast 16ch 3.0T Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| May 16, 2022 | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 5, 2022 | K214081 | MRCAT Head & Neck | MUJ | Substantially Equivalent | Philips OY | accessdata.fda.gov |
| March 3, 2022 | K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | 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 |
| November 19, 2021 | K212673 | MR 5300 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 29, 2021 | K213351 | ds Head 32ch 3.0T | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | 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 |
| January 24, 2020 | K193109 | MRCAT brain | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | 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 30, 2019 | K182888 | MRCAT Pelvis | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | accessdata.fda.gov |
| February 14, 2019 | K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 3, 2018 | K181479 | Ingenia Ambition S and Ingenia Ambition X | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | 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 20, 2018 | K173451 | Ingenia Elition S and Ingenia Elition X | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 6, 2018 | K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | 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 |
| January 6, 2017 | K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| November 7, 2016 | K162863 | dS Small Extremity 16CH 1.5T Coil | MOS | Substantially Equivalent | Invivo Therapeutics Corporation | accessdata.fda.gov |
| September 14, 2016 | K162177 | dS FootAnkle I6CH 1.5T Coil | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 31, 2016 | K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| March 22, 2016 | K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | LNH | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| February 25, 2016 | K151435 | MRCAT | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | accessdata.fda.gov |
| December 21, 2012 | K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | MOS | Substantially Equivalent | Invivo Corporation | 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 |
| November 2, 2012 | K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| February 10, 2012 | K120122 | SENSE MSK S 8CH 1.5T | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| December 23, 2011 | K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 25, 2011 | K112112 | SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS | MOS | Substantially Equivalent | Sentinel Medical, Inc. | accessdata.fda.gov |
| August 18, 2011 | K103274 | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING | MOS | Substantially Equivalent | Sentinelle Medical, Inc. | accessdata.fda.gov |
| March 22, 2011 | K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T | LNH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| January 3, 2011 | K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| April 22, 2010 | K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 | MOS | Substantially Equivalent | Sentinelle Medical, Inc. | accessdata.fda.gov |
| March 5, 2010 | K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| February 1, 2010 | K093284 | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 21, 2009 | K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| November 6, 2008 | K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| October 15, 2008 | K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| November 16, 2007 | K072873 | LBS-63-16 BREAST ARRAY COIL | MOS | Substantially Equivalent | Invivo | 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 |
| July 28, 2006 | K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| April 14, 2006 | K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS | MOS | Substantially Equivalent | Sentinelle Medical, Inc. | accessdata.fda.gov |
| November 16, 2005 | K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 12, 2005 | K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | MOS | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| September 7, 2005 | K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 2, 2005 | K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 8, 2005 | K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| April 7, 2005 | K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| March 25, 2005 | K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| February 24, 2005 | K050299 | HRK-123 KNEE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| February 15, 2005 | K043147 | ACHIEVA FAMILY | LNH | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| August 16, 2004 | K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| July 26, 2004 | K041602 | PANORAMA 1.0T | LNH | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| July 19, 2004 | K041481 | MODEL BBC-127 BIOPSY BREAST COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| May 14, 2004 | K041185 | TORSO ARRAY COIL, MODEL 558GE-64 | MOS | Substantially Equivalent | Igc-Medical Advances, Inc. | accessdata.fda.gov |
| March 9, 2004 | K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 9, 2004 | K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 5, 2004 | K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| November 25, 2003 | K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| October 23, 2003 | K032576 | BIOPSY BREAST COIL, MODEL BBC | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| October 10, 2003 | K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| October 10, 2003 | K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 25, 2003 | K032633 | HRK-63-8 KNEE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 10, 2003 | K031815 | INTERA-SENSATION FAMILY | LNH | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| August 21, 2003 | K032429 | QSC-127 SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 6, 2003 | K030520 | INTERA FAMILY | LNH | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| January 9, 2003 | K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| January 9, 2003 | K024209 | QWH-250-PAN WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| January 7, 2003 | K024208 | OBC-250-PAN BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| December 16, 2002 | K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL | MOS | Substantially Equivalent | Medical Advances, Inc. | accessdata.fda.gov |
| October 3, 2002 | K022910 | QSC-63-INT SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 27, 2002 | K022883 | HRK-63 KNEE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 4, 2002 | K022588 | HRW-63-INT WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 23, 2002 | K022488 | MODEL OBC-63 BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 13, 2002 | K022372 | HRH-127-8 HEAD ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 13, 2002 | K021631 | ISA-21 INTERVENTIONAL SPINE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| June 12, 2002 | K021575 | OBC-127 BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| June 6, 2002 | K020850 | GPF-29 GENERAL PURPOSE COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 13, 2002 | K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Breast Biopsy / Localization Tray
- All makers of Set, I.V. Fluid Transfer
Updated July 30, 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.