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"
241–264 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
K242981 · MSW
Siemens Healthcare Diagnostics, Inc.
Immunology · 267d
Cleared Jun 20, 2025
Celsi Warmer
K242964 · DWJ
Hadleigh Health Technologies
Cardiovascular · 267d
Cleared Jun 18, 2025
F&P Nova Nasal Mask
K243583 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 210d
Cleared Jun 18, 2025
Happy Health Home Sleep Test
K242224 · MNR
Happy Health, Inc.
Anesthesiology · 324d
Cleared Jun 17, 2025
uOmniscan
K243666 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Jun 16, 2025
MAGNETOM Avanto Fit
K250443 · LNH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
K243512 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 210d
Cleared Jun 06, 2025
TYBR Collagen Gel
K250109 · OWY
Tybr Health
Orthopedic · 141d
Cleared Jun 06, 2025
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract,...
K243694 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 189d
Cleared Jun 06, 2025
Empatica Health Monitoring Platform
K242737 · MWI
Empatica S.R.L.
Cardiovascular · 268d
Cleared Jun 05, 2025
TechLive
K243703 · LLZ
DeepHealth, Inc.
Radiology · 188d
Cleared Jun 05, 2025
Central Station
K242750 · MSX
Nihon Kohden Digital Health...
Cardiovascular · 266d
Cleared Jun 04, 2025
Ultrasound Stimulator
K240788 · IMI
Jkh Health Co., Ltd.
Physical Medicine · 439d
Cleared Jun 03, 2025
EVAC
K243205 · JXG
Phasor Health, LLC
Neurology · 245d
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared May 19, 2025
Diagnostic X-ray System
K243411 · OWB
Nanjing Perlove Medical Equipment...
Radiology · 199d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 296d
Cleared May 14, 2025
CaloPix
K250414 · QKQ
Tribun Health
Pathology · 90d