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"
2953–2976 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 05, 2004
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K033777 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Jan 21, 2004
AMERSHAM HEALTH NEEDLE-GUARD
K033409 · FMI
Gettig Pharmaceutical Instrument Co.
General Hospital · 89d
Cleared Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 107d
Cleared Jan 08, 2004
CO2 CALIBRATOR/DILUENT
K033643 · JIT
Bayer Healthcare, Diagnostics Division
Chemistry · 49d
Cleared Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
K032563 · JHI
Bayer Healthcare, LLC
Chemistry · 125d
Cleared Dec 19, 2003
T-TECH DIGITAL, MODEL WL-22XXA SERIES
K033857 · GZJ
Well-Life Healthcare, Inc.
Neurology · 8d
Cleared Dec 19, 2003
LIFESTYLES LIQUID PERSONAL LUBRICANT
K033076 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 81d
Cleared Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
K031947 · KQO
Bayer Healthcare, LLC
Chemistry · 178d
Cleared Dec 17, 2003
BAYER RAPIDLAB 1200 SYSTEM
K031560 · CHL
Bayer Healthcare, LLC
Chemistry · 212d
Cleared Dec 08, 2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K032827 · KSR
Tyco Healthcare
Hematology · 89d
Cleared Dec 05, 2003
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
K032821 · NPP
Hygia Health Services, Inc.
Cardiovascular · 91d
Cleared Dec 01, 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC...
K032696 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Nov 28, 2003
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
K031374 · GZJ
Besmed Health Business Corp
Neurology · 212d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
K031676 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Nov 20, 2003
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
K031375 · IPF
Besmed Health Business Corp
Physical Medicine · 204d