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"
1105–1128 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Nov 22, 2019
LEva Pelvic Digital Health System
K192270 · HIR
Renovia, Inc.
Obstetrics & Gynecology · 92d
Cleared Nov 21, 2019
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839 · LFD
Oralabs, Inc.
Dental · 498d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Nov 19, 2019
RSI-MRI+
K191278 · LLZ
Multimodal Imaging Services...
Radiology · 190d
Cleared Nov 18, 2019
Digital Thermometer
K183393 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 09, 2019
Omics Core
K190661 · PZM
Nanthealth, Inc.
Pathology · 240d
Cleared Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · PIF
Cardinalhealth
Gastroenterology & Urology · 212d
Cleared Nov 04, 2019
DRX-Evolution/Plus with Dual Energy
K190330 · KPR
Carestream Health, Inc.
Radiology · 263d
Cleared Nov 01, 2019
COPAL exchange G Hip and Knee Spacers
K191016 · KWY
Heraeus Medical GmbH
Orthopedic · 198d
Cleared Nov 01, 2019
Foryou NPWT Dressing Kit
K190119 · OMP
4l Health Co., Ltd.
General & Plastic Surgery · 281d
Cleared Oct 31, 2019
Claritag
K190747 · GEH
Dgi Technologies
General & Plastic Surgery · 223d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
K192705 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 28d
Cleared Oct 19, 2019
Altapore Shape
K191513 · MQV
Baxter Healthcare Corporation
Orthopedic · 134d
Cleared Oct 18, 2019
BIAFINE Topical Cream
K190342 · FRO
Bausch Health Americas Incorporated
General & Plastic Surgery · 246d
Cleared Oct 17, 2019
Merge PACS
K192455 · LLZ
Merge Healthcare Incorporated
Radiology · 38d
Cleared Oct 11, 2019
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask...
K190713 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Oct 11, 2019
Protego Antimicrobial Wound Dressing
K183681 · FRO
Global Health Solutions (Dba Turn...
General & Plastic Surgery · 287d
Cleared Oct 10, 2019
VERA
K192474 · LXJ
Reflexion Health, Inc.
Physical Medicine · 30d
Cleared Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K190208 · FFX
Diversatek Healthcare
Gastroenterology & Urology · 241d
Cleared Oct 01, 2019
Signa Voyager, Signa Voyager Quantum
K192426 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 26d
Cleared Sep 25, 2019
NuStat
K183190 · POD
Beeken Biomedical, LLC
General & Plastic Surgery · 310d