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"
457–480 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 27, 2023
Digital Expert Access with Remote Scanning
K232346 · LNH
Ge Healthcare
Radiology · 84d
Cleared Oct 27, 2023
Cold/Hot Compression
K223541 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 336d
Cleared Oct 24, 2023
Aco Apache Ultrasound System
K231509 · IYN
Aco Healthcare Co., Ltd.
Radiology · 152d
Cleared Oct 20, 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · KGO
Ansell Healthcare
General Hospital · 114d
Cleared Oct 20, 2023
Sonix Health
K230209 · QIH
Ontact Health Co., Ltd.
Radiology · 268d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 16, 2023
ANDORATE® Valve Kit
K232118 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 91d
Cleared Oct 16, 2023
Iontophoresis Electrodes
K232020 · EGJ
Top-Rank Health Care Co., Ltd.
Physical Medicine · 101d
Cleared Oct 12, 2023
Scenaria View 4.2
K231574 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 134d
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