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"
3025–3048 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 87d
Cleared Nov 14, 2003
SPIROPRO SPO2
K031515 · DQA
Viasys Healthcare GmbH
Anesthesiology · 184d
Cleared Nov 13, 2003
MONOJECT INSULIN SYRINGE
K033373 · FMI
Tyco Healthcare
General Hospital · 22d
Cleared Nov 13, 2003
MPS ACACIA SAFEGUARD HUBER DEVICE
K032934 · FPA
Mps Acacia
General Hospital · 52d
Cleared Nov 13, 2003
NAVIGATOR I
K032879 · INI
Adaptive Healthcare Technologies, Inc.
Physical Medicine · 59d
Cleared Nov 13, 2003
HOSPITAL SPACER
K032809 · CAF
Respironics Healthscan, Inc.
Anesthesiology · 65d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR...
K032444 · LZC
Cardinalhealth
General Hospital · 97d
Cleared Nov 06, 2003
VITERION 100 TELEHEALTH MONITOR
K030419 · MWI
Viterion Telehealthcare, LLC
Cardiovascular · 269d
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388 · MYU
Cardinalhealth
Neurology · 88d