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"
3001–3024 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 25, 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · FRN
Baxter Healthcare Corp
General Hospital · 50d
Cleared Jun 22, 2004
GE DISCOVERY ST
K041543 · KPS
Ge Healthcare
Radiology · 14d
Cleared Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K040425 · NBC
Bayer Healthcare, LLC
Chemistry · 117d
Cleared Jun 10, 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · CAF
Cardinalhealth
Anesthesiology · 14d
Cleared Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 59d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared May 28, 2004
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · LCO
Akers Laboratories, Inc.
Hematology · 112d
Cleared May 27, 2004
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND...
K040512 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared May 19, 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · GXP
Cardinalhealth
Neurology · 117d
Cleared May 07, 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · LZC
Cardinalhealth
General Hospital · 155d
Cleared May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
K040506 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 68d
Cleared May 05, 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · LZH
Tyco Healthcare/Kendall
General Hospital · 97d
Cleared Apr 29, 2004
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · FRO
Tyco Healthcare
General & Plastic Surgery · 182d
Cleared Apr 27, 2004
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
K033905 · KGO
Cardinalhealth
General Hospital · 132d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 13d
Cleared Apr 13, 2004
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
K033710 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Apr 13, 2004
TELECARE D.R. SERVER SOFTWARE SYSTEM
K033133 · MWI
Healthcare Vision, Inc.
Cardiovascular · 196d
Cleared Apr 07, 2004
MASTERSCREEN CPX AND OXYCON CPX
K040698 · BZC
Viasys Healthcare GmbH
Anesthesiology · 21d
Cleared Apr 02, 2004
TRUST
K040718 · CAF
Dhd Healthcare Corp.
Anesthesiology · 14d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
United States Surgical, A Division of...
Orthopedic · 23d
Cleared Mar 10, 2004
HEALTH BUDDY WITH BUDDYLINK
K040086 · DXN
Health Hero Network, Inc.
Cardiovascular · 54d
Cleared Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 20d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · JIX
Bayer Healthcare, LLC
Chemistry · 71d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Omron Healthcare, Inc.
Cardiovascular · 201d