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"
1–24 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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 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
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 · NAY
Auris Health, Inc., part of Johnson &...
General & Plastic Surgery · 215d
Cleared Jul 15, 2026
Profoject™ Pen Needles (Model A
K260739 · FMI
CMT Health PTE., Ltd.
General Hospital · 131d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jul 02, 2026
FUJIFILM Processor EP-8000
K261880 · FET
Fujifilm Corporation
Gastroenterology & Urology · 27d
Cleared Jul 02, 2026
iPredict-DR
K253704 · PIB
iHealthscreen, Inc.
Ophthalmic · 220d
Cleared Jun 25, 2026
G-Series Grind Guard
K260790 · OBR
ASESSO HEALTH, Inc.
Dental · 106d
Cleared Jun 22, 2026
Health Line Tearaway Introducer
K261950 · DYB
Health Line International Corporation
Cardiovascular · 12d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729 · QAS
GuideAI Health
Radiology · 104d
Cleared Jun 18, 2026
inspired™ Heated Breathing Circuit (510-008)
K252066 · BZE
Vincent Healthcare Products Limited
Anesthesiology · 352d
Not Cleared Jun 18, 2026
Syncron-E
DEN250025 · QVC
Autonomous Healthcare, Inc.
Anesthesiology · 360d
Cleared Jun 16, 2026
myAblation Guide (VC10A)
K253264 · QTZ
Siemens Healthcare GmbH
Radiology · 260d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared Jun 15, 2026
DRE Duo
K260482 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 122d