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"
2113–2136 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 10, 2012
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
K113612 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 66d
Cleared Feb 01, 2012
FREEMIE (R)
K111411 · HGX
Dao Health
Obstetrics & Gynecology · 257d
Cleared Jan 30, 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
K111413 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 255d
Cleared Jan 27, 2012
MODEL HBP-1300
K113185 · DXN
Omron Healthcare, Inc.
Cardiovascular · 91d
Cleared Jan 26, 2012
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
K112959 · DPS
Philips Health Care
Cardiovascular · 114d
Cleared Jan 23, 2012
PCXX VARNISH
K113146 · LBH
Ross Healthcare, Inc.
Dental · 91d
Cleared Jan 20, 2012
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · FRG
Cardinal Health200, LLC
General Hospital · 109d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · LIP
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d
Cleared Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · JZG
Siemens Healthcare Diagnostics, Inc.
Immunology · 297d
Cleared Jan 10, 2012
VOLUSON E6/E8/E8EXPERT/E10
K113758 · IYE
Ge Healthcare
General & Plastic Surgery · 20d
Cleared Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 128d
Cleared Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 29, 2011
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · IYN
Ge Healthcare
Radiology · 14d
Cleared Dec 22, 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K111324 · MUE
Agfa Healthcare N.V.
Radiology · 225d
Cleared Dec 21, 2011
TCX-I REMOTE CARE MANAGEMENT SYSTEM
K113493 · DRG
Bl Healthcare, Inc.
Cardiovascular · 26d
Cleared Dec 21, 2011
GALAXY SYSTEM
K111055 · OLV
Personal Health Institute International
Neurology · 250d
Cleared Dec 13, 2011
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
K113034 · IZI
Ge Healthcare
Radiology · 63d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY...
K111830 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 08, 2011
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · FPB
Baxter Healthcare Corp
General Hospital · 37d
Cleared Dec 08, 2011
MODEL PM3030
K110068 · NUH
Omron Healthcare, Inc.
Neurology · 332d
Cleared Dec 05, 2011
BRIVO NM 615
K113350 · KPS
Ge Healthcare
Radiology · 21d
Cleared Dec 02, 2011
VOCARE MYHEALTH TABLET
K111922 · DRG
Vocare, Inc.
Cardiovascular · 149d
Cleared Nov 30, 2011
CENTRICITY CARDIO IMAGING
K112570 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 85d