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"
1897–1920 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 24, 2013
SHENGGUANG MANUAL WHEELCHAIR
K131529 · IOR
Pingdingshan Shenxing Healthcare...
Physical Medicine · 119d
Cleared Sep 17, 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · LLZ
Ge Healthcare
Radiology · 81d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 13, 2013
LOBSTER AUTO-INJECTOR
K124026 · KZH
Scandinavian Health Limited
General Hospital · 259d
Cleared Sep 11, 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · DQA
Andon Health Co, Ltd.
Anesthesiology · 145d
Cleared Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
K130349 · HGX
Dao Health
Obstetrics & Gynecology · 206d
Cleared Aug 29, 2013
CR 12-X DIGITIZER
K131408 · MQB
Agfa Healthcare N.V.
Radiology · 106d
Cleared Aug 28, 2013
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
K131582 · JAD
Sensus Healthcare
Radiology · 89d
Cleared Aug 28, 2013
CARESCAPE MONITOR B850
K131414 · MHX
GE Healthcare Finland Oy
Cardiovascular · 104d
Cleared Aug 28, 2013
CARESCAPE MONITOR B650
K131223 · MHX
GE Healthcare Finland Oy
Cardiovascular · 120d
Cleared Aug 26, 2013
LOGIQ S8
K131527 · IYN
Ge Healthcare
Radiology · 90d
Cleared Aug 20, 2013
KIMGUARD ONE STEP STERILIZATION WRAP
K113806 · FRG
Kimberly-Clark Health Care
General Hospital · 606d
Cleared Aug 14, 2013
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
K123882 · DXN
Ageless Health Industrial
Cardiovascular · 240d
Cleared Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
K131536 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 75d
Cleared Jul 30, 2013
BROADMASTER HEALTHCARE SYSTEM
K130621 · NBW
Broadmaster Biotech Corporation
Chemistry · 144d
Cleared Jul 30, 2013
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
K122458 · DRG
Cello Partnership D/B/A Verizon Wireless
Cardiovascular · 351d
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Philips Health Care
Radiology · 19d
Cleared Jul 24, 2013
HEM-6131
K131742 · DXN
Omron Healthcare, Inc.
Cardiovascular · 41d
Cleared Jul 23, 2013
SPACELABS HEALTHCARE CARDIOEXPRESS
K130207 · DPS
Spacelabs Healthcare, Ltd.
Cardiovascular · 176d
Cleared Jul 19, 2013
IHEALTH CLOUD
K131203 · DXN
Andon Health Co, Ltd.
Cardiovascular · 81d
Cleared Jul 18, 2013
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE...
K131046 · JOW
Venous Health Systems, Inc.
Cardiovascular · 94d
Cleared Jul 15, 2013
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
K130360 · DRG
Constant Care, LLC
Cardiovascular · 152d
Cleared Jul 12, 2013
INGENUITY DIGITAL PET/CT
K123599 · KPS
Philips Healthcare (Cleveland)
Radiology · 233d
Cleared Jul 11, 2013
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B
K123075 · NGX
Well-Life Healthcare Limited
Physical Medicine · 283d