FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123361–123384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1990
HDL CHOLESTEROL CONTROL
K904872 · JJY
Analytical Control Systems, Inc.
Chemistry · 38d
Cleared Dec 07, 1990
DIASTAT ENA PROFILE
K905190 · LJM
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM
K905191 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM/RNP
K905192 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 06, 1990
TRACH-EZE
K903740 · BSY
Sorex Medical
Anesthesiology · 112d
Cleared Dec 06, 1990
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 104d
Cleared Dec 06, 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · DTN
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Dec 06, 1990
CLINICAL CHEMISTRY CONTROL
K904075 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 93d
Cleared Dec 06, 1990
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
K904143 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 90d
Cleared Dec 06, 1990
SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
K904171 · DTR
Scimed
Cardiovascular · 86d
Cleared Dec 06, 1990
GUIDEWIRE
K904477 · DQX
Datascope Corp.
Cardiovascular · 66d
Cleared Dec 06, 1990
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
K904782 · LCX
Carter Products
Chemistry · 45d
Cleared Dec 06, 1990
SHUR-LOCK ICE WRAP SYSTEM
K904819 · IMD
Conco Medical Co.
Physical Medicine · 43d
Cleared Dec 06, 1990
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
K904829 · JJY
Analytical Control Systems, Inc.
Chemistry · 42d
Cleared Dec 06, 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968 · JJY
Baxter Healthcare Corp
Chemistry · 31d
Cleared Dec 06, 1990
ELEGANCE GH ELISA
K905098 · CFL
Bioclone Australia Pty , Ltd.
Chemistry · 23d
Cleared Dec 06, 1990
SYSTEM 90 AND 95
K905293 · ITI
Folio Products, Inc.
Physical Medicine · 13d
Cleared Dec 05, 1990
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K900464 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 308d
Cleared Dec 05, 1990
37-702 AND 37-703 PC RAINBOW
K900932 · IYI
Victoreen, Inc.
Radiology · 280d
Cleared Dec 05, 1990
ADVANCE DISPOSABLE STOPCOCK
K902724 · FMG
Advance Medical Designs, Inc.
General Hospital · 167d
Cleared Dec 05, 1990
DISPOSABLE EMISSIONS BARRIER LASER DRAPE
K903346 · KKX
Wave-Form Systems, Inc.
General Hospital · 133d
Cleared Dec 05, 1990
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH
K903417 · LIT
Vas-Cath, Inc.
Cardiovascular · 127d
Cleared Dec 05, 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
K903461 · KWP
Danek Medical, Inc.
Orthopedic · 126d
Cleared Dec 05, 1990
DENE BRIDGE
K903672 · EKO
Dirotian Pty. , Ltd.
Dental · 113d