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"
3577–3600 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 13, 1997
PIVOTAL SCISSOR
K972510 · GEI
Urohealth Systems, Inc.
General & Plastic Surgery · 133d
Cleared Nov 12, 1997
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID...
K973036 · MGP
3M Healthcare
General & Plastic Surgery · 90d
Cleared Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 10, 1997
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · MAI
United States Surgical, A Division of...
Orthopedic · 314d
Cleared Nov 07, 1997
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · EZD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 50d
Cleared Nov 06, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973551 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 48d
Cleared Nov 06, 1997
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER,...
K972203 · CBK
Allied Healthcare Products, Inc.
Anesthesiology · 148d
Cleared Nov 03, 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · MAI
United States Surgical, A Division of...
Orthopedic · 62d
Cleared Nov 03, 1997
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT...
K964926 · ILJ
Joerns Healthcare, Inc.
Physical Medicine · 329d
Cleared Oct 24, 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · LHI
Baxter Healthcare Corp
General Hospital · 29d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680 · MTJ
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Oct 22, 1997
AHCS HEMOPERFUSION SYSTEM
K971015 · FLD
American Health Care Systems, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 10, 1997
PACER MODEL 100 INFUSION CONTROLLER
K963136 · LDR
Health Watch, Inc.
General Hospital · 423d
Cleared Oct 10, 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · LHI
Baxter Healthcare Corp
General Hospital · 577d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE...
K972579 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Sep 26, 1997
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
K970253 · KDI
Gambro Healthcare
Gastroenterology & Urology · 247d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Sep 19, 1997
IMPERVIOUS ISOLATION GOWN
K972410 · FYC
Kentron Health Care, Inc.
General Hospital · 85d
Cleared Sep 19, 1997
KENTRON'S ISOLATION GOWN
K971917 · FYC
Kentron Health Care, Inc.
General Hospital · 119d
Cleared Sep 12, 1997
PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K972009 · KGO
Tillotson Healthcare Corp.
General Hospital · 105d
Cleared Sep 12, 1997
BABY DOPPLEX (3000)
K963711 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 361d
Cleared Sep 09, 1997
BLOOD MONITOR PUMP
K970591 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 203d