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

5,274 results for "health"
1–24 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 29, 2026
Syngo Carbon Space (VA4)
K263048 · LLZ
Siemens Healthineers AG
Radiology · 29d
Cleared Sep 25, 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · JKA
CMT Health PTE., Ltd.
General Hospital · 87d
Cleared Sep 25, 2026
Profoject™ LOR Syringe
K261372 · CAZ
CMT Health PTE., Ltd.
Anesthesiology · 151d
Cleared Sep 25, 2026
Aevice Wheeze Detection Module
K260140 · PHZ
Aevice Health Pte. , Ltd.
Anesthesiology · 248d
Cleared Sep 23, 2026
Hair Growth Comb (X-GC01)
K262254 · OAP
Guangdong Ashmore Health Technology...
General & Plastic Surgery · 83d
Cleared Sep 22, 2026
Echo-2
K254240 · QOK
Neko Health AB
Cardiovascular · 267d
Cleared Sep 18, 2026
SCENARIA View Phase 6.0
K261229 · JAK
Fujifilm Corporation
Radiology · 156d
Cleared Sep 16, 2026
APERTO Lucent MRI System
K261283 · LNH
Fujifilm Corporation
Radiology · 152d
Cleared Sep 10, 2026
Upper Arm Blood pressure monitor (BP7155D)
K261929 · DXN
Omron Healthcare, Inc.
Cardiovascular · 93d
Cleared Sep 09, 2026
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs...
K261793 · LZA
Maxter Healthcare, Inc.
General Hospital · 103d
Cleared Sep 04, 2026
IMMULITE 2000 3gAllergy Specific IgE Vantage
K260331 · DHB
Siemens Healthcare Diagnostics...
Immunology · 214d
Cleared Sep 04, 2026
FCT iStream Phase 2
K253836 · JAK
Fujifilm Corporation
Radiology · 277d
Cleared Sep 04, 2026
Peerbridge COR MDx (Cor MDx)
K253529 · MWJ
Peerbridge Health, Inc.
Cardiovascular · 295d
Cleared Sep 03, 2026
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model:...
K261622 · HGX
Philips Consumer Lifestyle B.V.
Obstetrics & Gynecology · 111d
Cleared Sep 03, 2026
Happy Health Blood Pressure Monitor
K254000 · DXN
Happy Health, Inc.
Cardiovascular · 262d
Cleared Sep 03, 2026
M•care System (MW-20)
K253673 · LQK
Marani Health, Inc.
Obstetrics & Gynecology · 286d
Cleared Sep 02, 2026
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with...
K261749 · LZA
Cardinalhealth
General Hospital · 97d
Cleared Sep 01, 2026
Carescape ONE
K260656 · MHX
GE Healthcare Finland Oy
Cardiovascular · 186d
Cleared Sep 01, 2026
AMI™ Plasma Cartridge, AMI™
K260613 · JID
Sequitur Health Corp.
Chemistry · 188d
Cleared Aug 28, 2026
Carescape Canvas 1000
K260343 · MHX
GE Healthcare Finland Oy
Cardiovascular · 207d
Cleared Aug 27, 2026
Optiflow Oxygen Kit (AA484J)
K262268 · BTT
Fisher and Paykel Healthcare Limited
Anesthesiology · 52d
Cleared Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
K261394 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 119d
Cleared Aug 21, 2026
uAngio AVIVA CX
K253726 · OWB
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Aug 20, 2026
Kneu Platform (V2)
K262515 · GYD
Kneu Health Digital , Ltd.
Neurology · 30d