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"
193–216 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · LJE
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 135d
Cleared Jul 02, 2025
Power Wheelchair (MOB1107)
K250729 · ITI
Vive Health, LLC
Physical Medicine · 113d
Cleared Jul 02, 2025
Compressor Nebulizer (NB-1100)
K243468 · CAF
Joytech Healthcare Co. , Ltd.
Anesthesiology · 236d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 26, 2025
Freedom® Total Knee System – Titanium Tibial Base Plate
K251717 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 22d
Cleared Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 121d
Cleared Jun 25, 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 29d
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