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

5,280 results for "health"
1873–1896 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2013
ADHESIVE ELECTRODES
K132588 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 95d
Cleared Nov 20, 2013
AGAMATRIX HEALTH MANAGER
K132821 · NBW
Agamatrix, Inc.
Chemistry · 72d
Cleared Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA...
K132376 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Nov 14, 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · DXN
Robert Bosch Healthcare Systems, Inc.
Cardiovascular · 216d
Cleared Nov 08, 2013
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
K132913 · IYN
Ge Healthcare
Radiology · 52d
Cleared Nov 08, 2013
K-Y BRAND LIQUIBEADS
K122061 · NUC
Johnson & Johnson Healthcare Products
Obstetrics & Gynecology · 483d
Cleared Nov 06, 2013
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 127d
Cleared Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
K132307 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 104d
Cleared Oct 30, 2013
IMMULITE 2000
K133122 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 24, 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 121d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971 · DRG
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
K122848 · MSS
Lenstec, Inc.
Ophthalmic · 395d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND...
K132734 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Oct 07, 2013
HEM-6221
K131749 · DXN
Omron Healthcare, Inc.
Cardiovascular · 115d
Cleared Oct 03, 2013
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 407d
Cleared Sep 27, 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · DQA
GE Healthcare Finland Oy
Anesthesiology · 29d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · NBW
Bayer Healthcare
Chemistry · 416d
Cleared Sep 24, 2013
VOLUSON I/E
K131937 · IYN
Ge Healthcare
Radiology · 89d
Cleared Sep 24, 2013
BRILLIANCE ICT
K131773 · JAK
Philips Healthcare (Cleveland)
Radiology · 99d