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"
49–72 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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 25, 2026
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B,...
K252584 · HIF
Weyo Surgical Technology , Ltd.
Obstetrics & Gynecology · 314d
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
Cleared Jun 15, 2026
Saige-Dx
K253825 · QDQ
DeepHealth, Inc.
Radiology · 196d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
Universal 1417PI
K252996 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 267d
Cleared Jun 12, 2026
Barbed PDO Suture
K252171 · NEW
Sutura Medical Technology, Inc.
General & Plastic Surgery · 337d
Cleared Jun 10, 2026
Profoject™ Safety Pen Needles
K260855 · FMI
CMT Health PTE., Ltd.
General Hospital · 86d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d