FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,275 results for "health"
409–432 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 24, 2024
uPMR 790
K234154 · OUO
Shanghai United Imaging Healthcare...
Radiology · 147d
Cleared May 23, 2024
Syngo Carbon Enterprise Access (VA40A)
K240294 · LLZ
Siemens Healthcare GmbH
Radiology · 112d
Cleared May 17, 2024
uOmnispace.CT
K233209 · QIH
Shanghai United Imaging Healthcare...
Radiology · 232d
Cleared May 14, 2024
Electric Breast Pump (BRP-301)
K233913 · HGX
Aoj Health Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 179d
Cleared May 08, 2024
F&P myAirvo 3
K222292 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 649d
Cleared May 03, 2024
ECHELON Synergy V10.0
K233687 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 168d
Cleared May 03, 2024
CT 5300
K232491 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 260d
Cleared May 02, 2024
VereSee Optical Veres Needle System
K232464 · HIF
Freyja Healthcare, LLC
Obstetrics & Gynecology · 261d
Cleared May 01, 2024
Cold Compression
K240986 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 21d
Cleared Apr 26, 2024
uMR Jupiter
K233673 · LNH
Shanghai United Imaging Healthcare...
Radiology · 162d
Cleared Apr 26, 2024
FCT iSTREAM Phase 1
K233583 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 171d
Cleared Apr 23, 2024
AEYE-DS
K240058 · PIB
Aeye Health, Inc.
Ophthalmic · 106d
Cleared Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
K234041 · DXN
Andon Health Co, Ltd.
Cardiovascular · 123d
Cleared Apr 17, 2024
uOmnispace.MR
K233186 · QIH
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Apr 12, 2024
OASIS MRI System
K240571 · LNH
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 12, 2024
Disposable Extension Set
K222766 · FPA
Shandong Ande Healthcare Apparatus...
General Hospital · 577d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Ge Healthcare Japan Corporation
Radiology · 146d
Cleared Apr 10, 2024
uMR 680
K240744 · LNH
Shanghai United Imaging Healthcare...
Radiology · 23d
Cleared Apr 10, 2024
Keikku Electronic stethoscope
K233313 · DQD
Lapsi Health Holding B.V.
Cardiovascular · 194d
Cleared Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 192d
Cleared Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
K232037 · PNE
Innovative Health, LLC
Cardiovascular · 269d
Cleared Apr 03, 2024
Oxevision Sleep Device
K233618 · LEL
Oxehealth Limited
Neurology · 142d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d