Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
80401–80424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2001
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING...
K003752 · JLW
Biosafe Laboratories, Inc.
Chemistry · 108d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · JGJ
Jas Diagnostics, Inc.
Chemistry · 101d
Cleared Mar 23, 2001
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K010389 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 42d
Cleared Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · JPK
Quantimetrix Corp.
Hematology · 23d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES...
K010636 · MVN
Ciba Vision Corporation
Ophthalmic · 18d
Cleared Mar 23, 2001
FLEXI-SITE SP02 EAR SENSOR
K010718 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 11d
Cleared Mar 22, 2001
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
K000724 · KDI
Medica S.R.L.
Gastroenterology & Urology · 381d
Cleared Mar 22, 2001
K.E.A.T.
K002154 · KPI
Emd Electronic Medical Devices, Corp.
Gastroenterology & Urology · 248d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 22, 2001
BLASTASSIST SYSTEM
K003156 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SYNVITRO FLUSH
K003163 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SUPRASPERM SYSTEM
K003404 · MQL
Medicult A/S
Obstetrics & Gynecology · 141d
Cleared Mar 22, 2001
ENDIUS BIPOLAR SHEATH
K003897 · GEI
Endius, Inc.
General & Plastic Surgery · 94d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037 · KNW
Daum GmbH
Gastroenterology & Urology · 77d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO
Sigma Diagnostics, Inc.
Hematology · 64d
Cleared Mar 22, 2001
MCC-MIV ONE 2 ONE SOFTWARE
K010364 · ITI
Invacare Corp.
Physical Medicine · 43d
Cleared Mar 22, 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · KWP
Interpore Cross Intl.
Orthopedic · 28d
Cleared Mar 21, 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · DYB
Arrow Intl., Inc.
Cardiovascular · 218d
Cleared Mar 21, 2001
WHITTLESTONE BREASTPUMP
K002696 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 203d
Cleared Mar 21, 2001
MEDEVIEW SYSTEM
K002789 · LLZ
Medeview.Com
Radiology · 195d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 124d
Cleared Mar 21, 2001
VENTURE HOME FILL II, MODEL IOH 200
K003939 · CAW
Invacare Corp.
Anesthesiology · 90d