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"
1153–1176 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jun 13, 2019
HealthICH
K190424 · QAS
Zebra Medical Vision, Ltd.
Radiology · 111d
Cleared Jun 13, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · DXN
Health & Life Co., Ltd.
Cardiovascular · 136d
Not Cleared Jun 07, 2019
IB-Stim
DEN180057 · QHH
Innovative Health Solutions (Ihs), Inc.
Neurology · 225d
Cleared Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183535 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared May 29, 2019
uMR 780, uMR 790
K191157 · LNH
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 27, 2019
Surgical Face Mask
K182515 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 128d
Cleared May 23, 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with...
K190018 · KGO
Ansell Healthcare Products, LLC
General Hospital · 139d