# FDA device clearances in Netherlands: 72 since Nov 2024

Updated October 22, 2026.

FDA made 72 device decisions for applicants in Netherlands from November 25, 2024 to October 22, 2026: 72 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 39 applicants. The newest, K262184 on October 22, 2026, is GANNET® from BAAT Medical Products B.V..

## The full list

FDA device clearances for applicants in Netherlands: 72 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 5 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/country/netherlands

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 72
- 510(k) and De Novo: 72
- PMA: 0
- Latest decision: October 22, 2026

## Newest decisions

The newest 72 of 72, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 22, 2026 | K262184 | GANNET® | BAAT Medical Products B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | JDO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262184) |
| October 14, 2026 | K262044 | Mediclose Cartridge System | Health Value Creation B.V. (trading as Corporis Medical) | Netherlands | Substantially Equivalent | 510(k) traditional | OCW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262044) |
| October 5, 2026 | K260523 | QGuideCT (1.0) | Medis Medical Imaging Systems BV | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260523) |
| September 9, 2026 | K261470 | QF10 | E.A.M Benelux B.V | Netherlands | Substantially Equivalent | 510(k) traditional | NHV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261470) |
| September 3, 2026 | K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips... | Philips Consumer Lifestyle B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261622) |
| August 21, 2026 | K260584 | BoneMRI | Mriguidance B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260584) |
| August 19, 2026 | DEN250046 | Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) | Vitestro | Netherlands | Unknown | De Novo | SIW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250046) |
| August 14, 2026 | K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | Netherlands | Substantially Equivalent | 510(k) special | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260898) |
| August 14, 2026 | K260559 | NHanceIT | IMDS Operation B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260559) |
| August 7, 2026 | K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | Netherlands | Substantially Equivalent | 510(k) special | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261437) |
| August 7, 2026 | K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254205) |
| 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... | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) special | MOS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262330) |
| July 26, 2026 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | MSX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261367) |
| July 24, 2026 | K262383 | LumenCare Azure | Nucletron B.V. | Netherlands | Substantially Equivalent | 510(k) special | JAQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262383) |
| 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... | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) special | MOS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262294) |
| July 24, 2026 | K254180 | PerfusiX-Imaging | LIMIS Development B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254180) |
| July 15, 2026 | K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260206) |
| July 10, 2026 | K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253670) |
| June 25, 2026 | K261242 | SimplGuide | Pendracare | Netherlands | Substantially Equivalent | 510(k) traditional | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261242) |
| May 27, 2026 | K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260207) |
| May 12, 2026 | K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260415) |
| May 7, 2026 | K254183 | MR Conditional Cup Electrodes | Technomed Europe | Netherlands | Substantially Equivalent | 510(k) traditional | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254183) |
| April 29, 2026 | K253682 | DeepHealth ProstateAI | Quantib B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253682) |
| April 2, 2026 | K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252198) |
| March 17, 2026 | K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253614) |
| March 16, 2026 | K254176 | SINEFIX | BAAT Medical Products B.V. | Netherlands | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254176) |
| March 15, 2026 | K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode... | Technomed Europe | Netherlands | Substantially Equivalent | 510(k) traditional | IKT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253581) |
| March 8, 2026 | K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253668) |
| March 5, 2026 | K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260169) |
| 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... | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253648) |
| January 29, 2026 | K252091 | Surgical Reality Viewer | Medicalvr B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252091) |
| January 29, 2026 | K251354 | UV Smart D60 | UV Smart Technologies B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | SCS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251354) |
| January 22, 2026 | K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253735) |
| January 16, 2026 | K254186 | Azurion R3.1 | Philips Medical Systems B.V. | Netherlands | Substantially Equivalent | 510(k) special | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254186) |
| January 15, 2026 | K251961 | SDS Growing Rod | BAAT Medical Products B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | PGM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251961) |
| 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 | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) special | MOS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254190) |
| January 12, 2026 | K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251524) |
| December 24, 2025 | K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253349) |
| December 23, 2025 | K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | Netherlands | Substantially Equivalent | 510(k) special | OHT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253754) |
| December 19, 2025 | K251037 | Rectal Applicator | Nucletron B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | JAQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251037) |
| November 18, 2025 | K252636 | Fluido Compact System | The Surgical Company International B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | LGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252636) |
| November 7, 2025 | K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | Netherlands | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250819) |
| November 3, 2025 | K250330 | 3mensio Workstation | Pie Medical Imaging BV | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250330) |
| October 24, 2025 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252645) |
| October 24, 2025 | K251827 | Azurion R3.1 | Philips Medical Systems B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251827) |
| October 2, 2025 | K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251215) |
| October 2, 2025 | K250766 | LungQ 4 | Thirona BV | Netherlands | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250766) |
| September 25, 2025 | K251527 | Brain WMH | Quantib B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251527) |
| September 12, 2025 | K251083 | Compact II | Enraf-Nonius, B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251083) |
| September 4, 2025 | K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | Netherlands | Substantially Equivalent | 510(k) traditional | LGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251733) |
| August 27, 2025 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | Netherlands | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241766) |
| July 15, 2025 | K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250181) |
| July 12, 2025 | K243199 | NightWatch+ US | Livassured BV | Netherlands | Substantially Equivalent | 510(k) traditional | POS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243199) |
| July 11, 2025 | K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia... | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) special | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251808) |
| July 3, 2025 | K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243220) |
| June 29, 2025 | K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | Netherlands | Substantially Equivalent | 510(k) traditional | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250972) |
| June 25, 2025 | K243112 | Curapuls 670 | Enraf-Nonius, B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | IMJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243112) |
| June 4, 2025 | K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) special | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251397) |
| May 30, 2025 | K250637 | VCFix Spinal System | Amber Implants | Netherlands | Substantially Equivalent | 510(k) traditional | NDN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250637) |
| May 23, 2025 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | Netherlands | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243474) |
| April 17, 2025 | K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242337) |
| April 4, 2025 | K243769 | QFR (3.0) | Qfr Solutions BV | Netherlands | Substantially Equivalent | 510(k) traditional | QHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243769) |
| April 4, 2025 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242001) |
| March 31, 2025 | K242166 | TribusConnect | Tribusmed Beheer BV | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242166) |
| March 19, 2025 | K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I... | Macromedics BV | Netherlands | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250429) |
| March 6, 2025 | K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243871) |
| February 10, 2025 | K243453 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | OHT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243453) |
| January 21, 2025 | K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242288) |
| December 11, 2024 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | Netherlands | Substantially Equivalent | 510(k) traditional | GXZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241045) |
| December 10, 2024 | K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242848) |
| December 2, 2024 | K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241871) |
| November 25, 2024 | K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241831) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Philips Medical Systems Nederland B.V. | 18 | August 7, 2026 |
| BAAT Medical Products B.V. | 3 | October 22, 2026 |
| Philips Consumer Lifestyle B.V. | 3 | September 3, 2026 |
| Philips Medical Systems B.V. | 3 | July 10, 2026 |
| Technomed Europe | 3 | May 7, 2026 |
| Screenpoint Medical B.V. | 2 | August 14, 2026 |
| Nucletron B.V. | 2 | July 24, 2026 |
| Pendracare | 2 | June 25, 2026 |
| Light Tree Ventures Europe B.V. | 2 | May 12, 2026 |
| Quantib B.V. | 2 | April 29, 2026 |
| Medical Brands Laboratories B.V. | 2 | April 2, 2026 |
| Onera B.V. | 2 | March 8, 2026 |
| Enraf-Nonius, B.V. | 2 | September 12, 2025 |
| Health Value Creation B.V. (trading as Corporis Medical) | 1 | October 14, 2026 |
| Medis Medical Imaging Systems BV | 1 | October 5, 2026 |
| E.A.M Benelux B.V | 1 | September 9, 2026 |
| Mriguidance B.V. | 1 | August 21, 2026 |
| Vitestro | 1 | August 19, 2026 |
| IMDS Operation B.V. | 1 | August 14, 2026 |
| The Surgical Company International B.V., doing business as TSC Life | 1 | August 7, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 31 | October 5, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 8 | August 14, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 6 | May 12, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 5 | October 22, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 5 | March 15, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 4 | August 19, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 4 | May 7, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 3 | October 14, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 3 | March 6, 2025 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 2 | July 3, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | September 3, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 57 | October 22, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 11 | August 14, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 3 | July 10, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | August 19, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).