FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
361–384 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 14, 2024
Clarius OB AI
K233955 · IYN
Clarius Mobile Health Corp.
Radiology · 182d
Cleared Jun 14, 2024
Smart Scope® CX
K233043 · HEX
Periwinkle Technologies Pvt., Ltd.
Obstetrics & Gynecology · 263d
Cleared Jun 13, 2024
F&P Optiflow Oxygen Kit (AA451J)
K233821 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 195d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 258d
Cleared Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · NLH
Innovative Health
Cardiovascular · 189d
Cleared Jun 03, 2024
ANNE Chest
K240251 · DRG
Sibel Health, Inc.
Cardiovascular · 125d
Cleared May 31, 2024
Bone Suppression Software
K240281 · LLZ
Konica Minolta, Inc.
Radiology · 120d
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · QYT
Ihealth Labs, Inc.
Microbiology · 179d
Cleared May 28, 2024
ANNE Limb
K240305 · DQA
Sibel Health, Inc.
Cardiovascular · 116d
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