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
166105–166128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1980
LINEAR ARRAY SCANNER
K800805 · DXK
Philips Medical Systems (Cleveland),...
Cardiovascular · 102d
Cleared Jul 21, 1980
ENTERAL & NASOGASTRIC SOL. ADMIN. SET
K800815 · KNT
G.D. Searle and Co.
Gastroenterology & Urology · 101d
Cleared Jul 21, 1980
HIGH STOY SMALL PARTS SCANNER #SP-100B
K800850 · DXK
Highstoy
Cardiovascular · 97d
Cleared Jul 21, 1980
VERIFY S PROD. #34141
K800925 · GGW
General Diagnostics
Hematology · 91d
Cleared Jul 21, 1980
ADAPTAID HELICAL COIL ADAPTER 365-14
K801039 · DTD
Intermedics, Inc.
Cardiovascular · 80d
Cleared Jul 21, 1980
TOTAL PROTEIN TEST
K801061 · CEK
Environmental Chemical Specialties
Chemistry · 76d
Cleared Jul 21, 1980
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K801070 · HHK
Sherwood Medical Industries
Obstetrics & Gynecology · 76d
Cleared Jul 21, 1980
THE SUN BOOTH
K801095 · LEJ
Sun Booths , Ltd.
Radiology · 73d
Cleared Jul 21, 1980
SUNBURST, SUN SYSTEMS OR BC2
K801163 · LEJ
Sun Ray Mfg., Inc.
Radiology · 67d
Cleared Jul 21, 1980
FOLATE RADIOASSAY KIT
K801198 · CGN
Calbiochem-Behring Corp.
Chemistry · 63d
Cleared Jul 21, 1980
EYE-VAC
K801231 · HKP
Coburn Optical Ind., Inc.
Ophthalmic · 55d
Cleared Jul 21, 1980
GDC 934
K801277 · EJS
Deringer-Ney, Inc.
Dental · 53d
Cleared Jul 21, 1980
HIPPURATE DISK
K801305 · JTC
Remel Co.
Microbiology · 48d
Cleared Jul 21, 1980
QUADRA WHEELCHAIR, QUADRA CHAIR, ETC.
K801317 · IQC
Quadra Wheelchairs, Inc.
Physical Medicine · 48d
Cleared Jul 21, 1980
SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
K801320 · JAA
General Electric Co.
Radiology · 48d
Cleared Jul 21, 1980
TAN YEAR ROUND SUN BED
K801341 · LEJ
Tan-Year Round, Inc.
Radiology · 46d
Cleared Jul 21, 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
K801344 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 46d
Cleared Jul 21, 1980
NEW FREEDOM ANYDAY PANTILINERS
K801358 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 42d
Cleared Jul 21, 1980
ALBUMIN NEPHELOMETRIC ASSAY
K801362 · JQX
J.T. Baker Chemical Co.
Chemistry · 42d
Cleared Jul 21, 1980
A2 IMAGE PROCESSING SYSTEM
K801368 · IYX
Medtronic Vascular
Radiology · 41d
Cleared Jul 21, 1980
GF-120-L DIALYZER
K801370 · FJI
Gambro, Inc.
Gastroenterology & Urology · 41d
Cleared Jul 21, 1980
K1 POTASSIUM ACETATE ADDITIVE
K801385 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 38d
Cleared Jul 21, 1980
HEMOHLOBIN A2 CONTROL-LYOPHILIZED
K801410 · JPD
Isolab, Inc.
Hematology · 35d
Cleared Jul 21, 1980
MAY ILLUMINATED/INFUSION PIC
K801411 · HMX
Cooper Medical Devices Corp.
Ophthalmic · 35d