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

5,276 results for "health"
937–960 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
K202753 · FLL
Andon Health Co, Ltd.
General Hospital · 168d
Cleared Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · DRF
Innovative Health, LLC
Cardiovascular · 120d
Cleared Mar 05, 2021
Andorate Universal Endoscope Tip Guard
K202838 · OCU
Ga Health Company Limited
Gastroenterology & Urology · 161d
Not Cleared Mar 05, 2021
ClearUP Sinus Relief
DEN200006 · QNU
Tivic Health Systems, Inc.
Ear, Nose, Throat · 392d
Cleared Feb 25, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE,...
K201142 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 302d
Cleared Feb 19, 2021
Inbrace Orthodontic System
K203442 · PNN
Swift Health Systems, Inc.
Dental · 88d
Cleared Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
K201425 · ITX
Huntleigh Healthcare Limited
Radiology · 266d
Cleared Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT
Ge Healthcare
General Hospital · 241d
Cleared Feb 06, 2021
MouthLab Vital Signs Monitoring System
K201635 · MWI
Multisensor Diagnostics (Dba Aidar...
Cardiovascular · 235d
Cleared Feb 05, 2021
Cios Spin
K210054 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 28d
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Jan 29, 2021
Sunset Heated CPAP Tube
K201418 · BZE
Sunset Healthcare Solutions, Inc.
Anesthesiology · 245d
Cleared Jan 26, 2021
IBM iConnect Access
K203104 · LLZ
Merge Healthcare Incorporated
Radiology · 104d
Cleared Jan 21, 2021
Overlapped Compression Therapy
K202839 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 118d
Cleared Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · CGR
Siemens Healthcare Diagnostics...
Chemistry · 71d
Cleared Jan 15, 2021
IMMULITE® 2000 Cortisol
K202826 · CGR
Siemens Healthcare Diagnostics...
Toxicology · 113d
Cleared Jan 12, 2021
Disposable Medical Surgical Mask
K201625 · FXX
Tianjin Saiyuan Technology Co., Ltd.
General Hospital · 211d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Dec 30, 2020
JianYu Surgical Mask
K201754 · FXX
Jiangsu Jianyu Health Medical Co., Ltd.
General Hospital · 184d
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073 · PTA
Helix Opco, LLC
Immunology · 509d
Cleared Dec 10, 2020
AquaPulse Irrigation Tubing
K202560 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 97d
Cleared Dec 07, 2020
HepaFat-AI
K201039 · LNH
Resonance Health Analysis Services...
Radiology · 231d
Cleared Dec 04, 2020
Nucleus.io
K203249 · LLZ
Nucleushealth, LLC
Radiology · 30d