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"
2161–2184 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 12, 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · DQK
Ge Healthcare
Cardiovascular · 166d
Cleared Oct 11, 2011
HEALTH-E-CONNECT SYSTEM
K102063 · NBW
Alr Technologies
Chemistry · 445d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Carestream Health, Inc.
Radiology · 122d
Cleared Oct 05, 2011
SPEACELABS MULTIGAS MODULE
K112173 · CBR
Spacelabs Healthcare
Anesthesiology · 69d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · NBW
Andon Medical Co., Ltd.
Chemistry · 10d
Cleared Sep 30, 2011
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K112320 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Ge Healthcare Japan Corporation
Radiology · 322d
Cleared Sep 29, 2011
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
K111878 · KGO
Cardinal Health, Inc.
General Hospital · 90d
Cleared Sep 27, 2011
LOGIQ P3
K112371 · IYN
Ge Healthcare
Radiology · 41d
Cleared Sep 26, 2011
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
K111614 · HGM
Ge Healthcare Integrated IT Solutions
Obstetrics & Gynecology · 110d
Cleared Sep 23, 2011
VENUE 40
K112122 · IYN
Ge Healthcare
Radiology · 60d
Cleared Sep 23, 2011
CS 7600
K111649 · MUH
Carestream Health, Inc.
Radiology · 102d
Cleared Sep 21, 2011
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA...
K111868 · KGO
Cardinal Health-Medical Products and...
General Hospital · 82d
Cleared Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061 · JJX
Siemens Healthcare Diagnostics
Chemistry · 254d
Cleared Sep 20, 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 46d
Cleared Sep 16, 2011
Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
K111278 · ITI
Otto Bock Healthcare LP
Physical Medicine · 134d
Cleared Sep 13, 2011
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K102483 · CAH
Sunset Healthcare Solutions, LLC
General Hospital · 379d
Cleared Sep 02, 2011
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES,...
K111139 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 133d
Cleared Sep 02, 2011
COMP A-I-R
K110860 · CAF
Omron Healthcare, Inc.
Anesthesiology · 157d
Cleared Sep 01, 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213 · IYN
Ge Healthcare
Radiology · 30d
Cleared Aug 30, 2011
MONICA IF24
K112163 · OSP
Monica Healthcare
Obstetrics & Gynecology · 34d
Cleared Aug 26, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI...
K102678 · NBW
Andon Medical Co., Ltd.
Chemistry · 344d
Cleared Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · LCP
Siemens Healthcare Diagnostics
Chemistry · 143d
Cleared Aug 24, 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 34d