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

5,281 results for "health"
3673–3696 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 24, 1996
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K963560 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Oct 24, 1996
PERSONAL BEST II
K962929 · BZH
Healthscan Products, Inc.
Anesthesiology · 87d
Cleared Oct 23, 1996
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Oct 21, 1996
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
K962250 · FNL
Carroll Healthcare, Inc.
General Hospital · 131d
Cleared Oct 21, 1996
PULSE DOSE SERIES
K961126 · NFB
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Oct 18, 1996
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · FPA
Baxter Healthcare Corp
General Hospital · 85d
Cleared Oct 17, 1996
OPTICHAMBER
K962822 · CAF
Healthscan Products, Inc.
Anesthesiology · 90d
Cleared Oct 11, 1996
SAFETY CRADLE
K962149 · FMI
Specialized Health Products, Inc.
General Hospital · 129d
Cleared Oct 11, 1996
FLOWTRON EXCEL PUMP
K961166 · JOW
Hne Healthcare, Inc.
Cardiovascular · 200d
Cleared Oct 10, 1996
BIOPSY INTRODUCER NEEDLE
K963390 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 43d
Cleared Oct 08, 1996
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K963253 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 50d
Cleared Sep 25, 1996
AUTO SUTURE SURGIWAND
K961771 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 140d
Cleared Sep 24, 1996
AMD HOME HEALTH MONITORING SYSTEM
K960337 · CGA
Advanced Medical Devices, Inc.
Chemistry · 244d
Cleared Sep 23, 1996
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 118d
Cleared Sep 20, 1996
COBE CENTRYSYSTEM 700 HG HEMODIALYZER
K962427 · KDI
Gambro Healthcare
Gastroenterology & Urology · 88d
Cleared Sep 20, 1996
CHIPS POWERED WHEELCHAIR
K955548 · ITI
International Healthcare Solutions, Inc.
Physical Medicine · 290d
Cleared Sep 20, 1996
CHIPS STANDUP WHEELCHAIR
K955547 · ITI
International Healthcare Solutions, Inc.
Physical Medicine · 290d
Cleared Aug 28, 1996
STOPCOCK MANIFOLD GANGS
K962581 · FMG
Baxter Healthcare Corp
General Hospital · 58d
Cleared Aug 28, 1996
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE...
K954623 · FKT
Gambro Healthcare
Gastroenterology & Urology · 328d
Cleared Aug 23, 1996
EQUIPMENT COVERS
K961699 · MMP
United States Surgical, A Division of...
General Hospital · 113d
Cleared Aug 22, 1996
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768 · LMA
Kodak Health Imaging Systems, Inc.
Radiology · 106d
Cleared Aug 15, 1996
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · CAF
Baxter Healthcare Corp
Anesthesiology · 72d
Cleared Aug 15, 1996
DHD ACE WITH MASK KIT
K961973 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared Aug 14, 1996
NHMC IRRIGATION TRAY
K962670 · LJH
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 36d