Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

660 results for "Philips Medical Systems"
1–24 of 660
Search insights Median review: 73d Cleared: 100% Top manufacturer: Philips Medical Systems (Cleveland), Inc. Lead specialty: Radiology
Cleared Aug 07, 2026
Zenition 30
K254205 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 221d
Cleared Jul 30, 2026
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS...
K262330 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d
Cleared Jul 10, 2026
SmartCT (R3.0 (L10))
K253670 · OWB
Philips Medical Systems B.V.
Radiology · 231d
Cleared May 27, 2026
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
K260207 · MUJ
Philips Medical Systems Nederland B.V.
Radiology · 124d
Cleared CT Mar 27, 2026
Spectral CT Verida Family
K253649 · JAK
Philips Medical Systems Technologies...
Radiology · 127d
Cleared Mar 23, 2026
CT Rembra RT
K252992 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 186d
Cleared Mar 17, 2026
EchoNavigator R5.0
K253614 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Mar 05, 2026
AV Cardiac CT
K260169 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 44d
Cleared Feb 23, 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal...
K253648 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 95d
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 16, 2026
Azurion R3.1
K254186 · OWB
Philips Medical Systems B.V.
Radiology · 24d
Cleared Jan 14, 2026
dS Base 1.5T
K254190 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Oct 24, 2025
LumiGuide Equipment R2.1
K252645 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 64d
Cleared Oct 24, 2025
Azurion R3.1
K251827 · OWB
Philips Medical Systems B.V.
Radiology · 133d
Cleared Oct 02, 2025
Philips IntelliSpace Cardiovascular
K251215 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 167d
Cleared Jul 15, 2025
AV Viewer
K250181 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared Jul 11, 2025
Achieva
K251808 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jun 27, 2025
Philips iCT CT system
K250648 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 115d
Cleared Jun 04, 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and...
K251397 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 16, 2025
Spectral CT
K244008 · JAK
Philips Medical Systems Technologies...
Radiology · 141d
Cleared CT Apr 04, 2025
Philips VSC-MEDlib
K242001 · BZQ
Philips Medical Systems Nederland B.V.
Anesthesiology · 269d
Cleared Mar 06, 2025
Philips IntelliSite Pathology Solution 5.1
K243871 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 79d
Cleared Dec 10, 2024
Philips IntelliSite Pathology Solution 5.1
K242848 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 81d