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

5,275 results for "health"
505–528 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 05, 2023
Clarius Ultrasound Scanner
K232704 · IYN
Clarius Mobile Health Corp.
Radiology · 30d
Cleared Oct 04, 2023
Momentum Spine
K232023 · LDK
Momentum Health, Inc.
Physical Medicine · 89d
Cleared Oct 03, 2023
endo.digital Platform
K232722 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 28d
Cleared Oct 03, 2023
uMI Panorama
K232712 · KPS
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Oct 03, 2023
Orchid Safety Release ValveTM
K232094 · QOI
Linear Health Sciences, LLC
General Hospital · 82d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 601d
Cleared Sep 18, 2023
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K231663 · LRK
Innovative Health Technologies (Nz),...
Dental · 103d
Cleared Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 28d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 182d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Sep 11, 2023
Change Healthcare Cardiology Hemodynamics™
K230881 · MWI
Change Healthcare Israel , Ltd.
Cardiovascular · 165d
Cleared Sep 08, 2023
CorVista® System
K232686 · QXX
Corvista Health, Inc.
Cardiovascular · 7d
Cleared Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231643 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 95d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Sep 08, 2023
Minuteful-kidney test
K222921 · JIR
Healthy.Io, Ltd.
Chemistry · 347d
Cleared Sep 08, 2023
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · LTK
Siemens Healthcare Diagnostics...
Immunology · 675d
Cleared Sep 07, 2023
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate,...
K230049 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 244d
Cleared Sep 05, 2023
F&P 820 Humidification System
K223684 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 271d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 56d
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for...
K223597 · QAZ
23AndMe, Inc.
Pathology · 272d
Cleared Aug 31, 2023
MedicloseTM System
K213271 · OCW
Health Value Creation B.V., Trading...
General & Plastic Surgery · 700d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · LRX
Phoenix Innovative Healthcare...
Ophthalmic · 132d
Cleared Aug 28, 2023
Alveoair Digital Spirometer
K222525 · BZG
Roundworks Technologies Private Limited
Anesthesiology · 371d