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"
3505–3528 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 29, 1997
VOLKER HOSPITAL BED, MODEL K960
K972115 · FNL
Volker Healthcare, Inc.
General Hospital · 85d
Cleared Aug 26, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K972013 · KNA
National Healthcare Mfg. Corp.
Obstetrics & Gynecology · 88d
Cleared Aug 13, 1997
ALICE 4R SYSTEM
K971867 · OLV
Healthdyne Technologies, Inc.
Neurology · 85d
Cleared Aug 12, 1997
AMERIGEL OINTMENT SATURATED WOUND DRESSING
K971918 · MGQ
Amerx Health Care Corp.
General & Plastic Surgery · 81d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Jul 29, 1997
SCAR CARE
K971009 · MDA
Target Health, Inc.
General & Plastic Surgery · 131d
Cleared Jul 28, 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · LYY
Allegiance Healthcare Corp.
General Hospital · 39d
Cleared Jul 25, 1997
PROTEGE LIQUID OXYGEN SYSTEM
K971545 · BYJ
Healthdyne Technologies, Inc.
Anesthesiology · 88d
Cleared Jul 24, 1997
CORELIFE
K964230 · FMF
Core Healthcare , Ltd.
General Hospital · 274d
Cleared Jul 23, 1997
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · CAK
Baxter Healthcare Corp
General Hospital · 44d
Cleared Jul 15, 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · MEB
Baxter Healthcare Corp
General Hospital · 106d