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"
1489–1512 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 30, 2016
OnSight 3D Extremity System
K160723 · JAK
Carestream Health, Inc.
Radiology · 167d
Cleared Aug 25, 2016
Exufiber Ag+
K160379 · FRO
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 197d
Cleared Aug 23, 2016
Cavilon Advanced High Endurance Skin Protectant
K153571 · KMF
3M Healthcare
General & Plastic Surgery · 252d
Cleared Aug 19, 2016
Electrosurgical disposable grounding pads
K160366 · ODR
Top-Rank Health Care Co., Ltd.
General & Plastic Surgery · 192d
Cleared Aug 19, 2016
iHealth Align Gluco-Monitoring system
K153286 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
Wireless Smart Gluco-Monitoring System
K153278 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 10, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160565 · DXN
Andon Health Co, Ltd.
Cardiovascular · 163d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Aug 03, 2016
iPEP System and vPEP
K160636 · BWF
D R Burton Healthcare, LLC
Anesthesiology · 149d
Cleared Aug 01, 2016
Infra-red forehead thermometer
K160999 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 112d
Cleared Aug 01, 2016
Senolris
K160937 · LLZ
Ge Healthcare
Radiology · 119d
Cleared Jul 28, 2016
Cardinal Health Isolation Gown
K160339 · FYC
Cardinal Health200, LLC
General Hospital · 171d
Cleared Jul 25, 2016
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · LYZ
Cardinal Health, Inc.
General Hospital · 160d
Cleared Jul 25, 2016
Skyn Original Polyisoprene Lubricated Male Condom
K160399 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 164d
Cleared Jul 14, 2016
Soberlink Cellular Device and Sober Sky Web Portal
K160613 · DJZ
Soberlink Healthcare, LLC
Toxicology · 133d
Cleared Jul 12, 2016
ARTLINE
K160448 · DQY
Health Line International Corporation
Cardiovascular · 145d
Cleared Jul 11, 2016
syngo®.via protoNeo (Version VA10A)
K161685 · LLZ
Siemens Healthcare GmbH
Radiology · 24d
Cleared Jul 11, 2016
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves...
K160875 · KGO
Cardinal Health, Inc.
General Hospital · 103d
Cleared Jul 06, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · DXN
Health & Life Co., Ltd.
Cardiovascular · 128d
Cleared Jun 29, 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)...
K151986 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 348d
Cleared Jun 24, 2016
Naya Breast Pump System
K160511 · HGX
Naya Health, Inc.
Obstetrics & Gynecology · 121d
Cleared Jun 22, 2016
IMPAX Volume Viewing 4.0
K161061 · LLZ
Agfa Healthcare N.V.
Radiology · 68d
Cleared Jun 14, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · NLH
Innovative Health, LLC
Cardiovascular · 109d