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"
3601–3624 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 06, 1996
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Aug 06, 1996
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · CBK
Allied Healthcare Products, Inc.
Anesthesiology · 222d
Cleared Aug 05, 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · HWE
Baxter Healthcare Corp
Orthopedic · 74d
Cleared Jul 31, 1996
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · CBI
Kendall Healthcare Products Co....
Anesthesiology · 72d
Cleared Jul 29, 1996
NHMC URETHRAL CATHETERIZATION TRAY
K962254 · FCM
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 47d
Cleared Jul 29, 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · LYY
Tillotson Healthcare Corp.
General Hospital · 195d
Cleared Jul 29, 1996
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT...
K960225 · LYY
Tillotson Healthcare Corp.
General Hospital · 194d
Cleared Jul 26, 1996
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968 · JIL
Tcpi, Inc.
Chemistry · 273d
Cleared Jul 25, 1996
HANC NETWORK
K952979 · DXN
Healthtech Services Corp.
Cardiovascular · 394d
Cleared Jul 18, 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · LJS
United States Surgical, A Division of...
General Hospital · 65d
Cleared Jul 16, 1996
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
K961997 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 55d