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"
2665–2688 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
K063036 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 80d
Cleared Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 77d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Dec 07, 2006
PRN THERMALCARE, MODEL 3000
K062794 · DWJ
American Healthcare Products, Inc.
Cardiovascular · 80d
Cleared Dec 06, 2006
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV,...
K062324 · MHX
Ge Healthcare
Cardiovascular · 119d
Cleared Nov 30, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 83d
Cleared Nov 28, 2006
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K063288 · FRN
Cardinal Health 303,Inc.
General Hospital · 27d
Cleared Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · NBW
Bayer Healthcare, LLC
Chemistry · 104d
Cleared Nov 21, 2006
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
K063291 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 20d
Cleared Nov 07, 2006
XERON PACS
K062757 · LLZ
Xeron Healthcare Corp.
Radiology · 54d
Cleared Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 03, 2006
SONARA
K060421 · IYN
Viasys Healthcare, Inc.
Radiology · 259d
Cleared Nov 02, 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 177d
Cleared Oct 27, 2006
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
K062016 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 102d
Cleared Oct 24, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · MSH
Inovel, LLC
General Hospital · 47d
Cleared Oct 23, 2006
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 18, 2006
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 89d
Cleared Oct 13, 2006
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
K060669 · GZJ
Healthonics, Inc.
Neurology · 213d
Cleared Oct 11, 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · MSH
Moldex/Metric, Inc.
General Hospital · 34d
Cleared Oct 11, 2006
VANGUARD REPROCESSED SUTURE PASSER
K053585 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 292d
Cleared Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138 · LZA
Molnlycke Health Care, Inc.
General Hospital · 71d
Cleared Sep 29, 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM...
K062576 · MHX
Ge Healthcare
Cardiovascular · 29d
Cleared Sep 29, 2006
DLM112 DAYLINK MONITOR
K062304 · DRG
Rtx Healthcare A/S
Cardiovascular · 52d