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"
25–48 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 19, 2026
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ...
K253431 · LXB
Shokz Health Global Limited
Ear, Nose, Throat · 322d
Cleared Aug 16, 2026
CN-Suite™
K260563 · OLX
FIND Surgical Sciences Inc. D/B/A...
Neurology · 178d
Cleared Aug 14, 2026
AdvaView
K262449 · LLZ
ADVAHEALTH SOLUTIONS, LLC
Radiology · 29d
Cleared Aug 14, 2026
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring
K260374 · GYD
Empatica S.R.L.
Neurology · 190d
Cleared Aug 13, 2026
VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
K261139 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 128d
Cleared Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
K253425 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 316d
Cleared Aug 12, 2026
BA-004CC
K261170 · ITX
Fujifilm Corporation
Radiology · 125d
Cleared Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
K253985 · DAP
Siemens Healthcare Diagnostic...
Hematology · 242d
Cleared Aug 10, 2026
Atellica IM CA 19-9 II
K253528 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 270d
Cleared Aug 07, 2026
EW10-EC02 Endoscopy Support Program
K260567 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 169d
Cleared Aug 03, 2026
XLITE
K260236 · IZL
GEMSS HEALTHCARE CO., LTD.
Radiology · 189d
Cleared Jul 31, 2026
MAGNETOM Flow.Elite
K260852 · LNH
Siemens Healthineers AG
Radiology · 137d
Cleared Jul 29, 2026
Profoject™ Dual-Safety Pen Needles
K261829 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Jul 28, 2026
uMI Panvivo (uMI Panvivo M)
K261427 · KPS
Shanghai United Imaging Healthcare...
Radiology · 89d
Cleared Jul 27, 2026
ND Needle Guidance System
K262474 · ITX
Accurate Access, LLC
Radiology · 10d
Cleared Jul 26, 2026
Corsano CardioWatch 287-2 System
K261367 · MSX
Corsano Health B.V.
Neurology · 90d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
K261364 · LDP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared Jul 24, 2026
Air Compression Massager (EP30B001 I)
K260948 · IRP
Wavepulse (Xiamen) Healthcare...
Physical Medicine · 123d
Cleared Jul 23, 2026
TRUE METRIX Self Monitoring Blood Glucose System
K262116 · NBW
Trividia Health, Inc.
Chemistry · 30d
Cleared Jul 23, 2026
Dental Cone-beam Computed Tomography (mDX-15P Series)
K261748 · OAS
Hefei Meyer Optoelectronic...
Radiology · 56d
Cleared Jul 23, 2026
CORE 300 Digital Stethoscope
K261694 · DQD
Eko Health, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2026
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
K261136 · DXN
Guangzhou Daxin Health Technology...
Cardiovascular · 107d
Not Cleared Jul 21, 2026
OTTAVA™ Robotic Surgical System
DEN250068 · SIR
Auris Health, Inc., part of Johnson &...
General & Plastic Surgery · 215d