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"
1105–1128 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 23, 2019
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · NLH
Innovative Health, LLC
Cardiovascular · 207d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Aug 09, 2019
ARIETTA 750
K191233 · IYN
Hitachi Healthcare Americas
Radiology · 93d
Cleared Aug 08, 2019
binx health io CT/NG Assay
K191352 · QEP
Binx Health, Inc.
Microbiology · 80d
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 29, 2019
Access CT
K191136 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 91d
Cleared Jul 29, 2019
Non-invasive blood pressure measurement systems
K190886 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 116d
Cleared Jul 29, 2019
Sample Imaging for Senographe Pristina
K190809 · MUE
Ge Healthcare
Radiology · 122d
Cleared Jul 26, 2019
Infrared Ear/Forehead Thermometer
K190873 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 114d
Cleared Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384 · JFY
Healthy.Io, Ltd.
Chemistry · 329d
Cleared Jul 25, 2019
PrisMax System Version 2
K190910 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 108d
Cleared Jul 18, 2019
DreaMed Advisor Pro
K191370 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 57d
Cleared Jul 18, 2019
Latitud Hip Replacement System
K183532 · LZO
Meril Healthcare Pvt. , Ltd.
Orthopedic · 211d
Cleared Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...
K191578 · QFO
Siemens Healthcare Diagnostics, Inc.
Microbiology · 33d
Cleared Jul 16, 2019
Sage 2-in-1 Personal Lubricant and Moisturizer
K190150 · NUC
Fairhaven Health, LLC
Obstetrics & Gynecology · 167d
Cleared Jul 12, 2019
Wearable Device, Wearable Package
K191272 · MSX
Current Health , Ltd.
Cardiovascular · 60d
Cleared Jul 10, 2019
Vave Personal Ultrasound System
K191541 · IYO
Vave Health, Inc.
Radiology · 29d
Cleared Jul 08, 2019
Microwave Ablation System
K183153 · NEY
Surgnova Healthcare Technologies...
General & Plastic Surgery · 236d
Cleared Jul 01, 2019
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K190980 · DRF
Innovative Health, LLC
Cardiovascular · 77d
Cleared Jun 25, 2019
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K190785 · NLG
Innovative Health, LLC
Cardiovascular · 90d
Cleared Jun 25, 2019
Radio Frequency Ablation System
K190052 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 165d
Cleared Jun 24, 2019
uWS-CT
K183170 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 220d
Cleared Jun 18, 2019
QLAB Advanced Quantification Software 13
K190913 · LLZ
Philips Health Care
Radiology · 71d