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
166945–166968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1980
TRITON
K801643 · INW
Chattanooga Group, Inc.
Physical Medicine · 11d
Cleared Jul 21, 1980
A-V MINI CLINIC
K800405 · DRT
Instromedix, Inc.
Cardiovascular · 146d
Cleared Jul 21, 1980
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
K800496 · KPF
American Medical Products, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 21, 1980
ULTRA IMAGER
K800553 · DXK
Honeywell, Inc.
Cardiovascular · 132d
Cleared Jul 21, 1980
VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
K800596 · DXN
Bib, Inc.
Cardiovascular · 126d
Cleared Jul 21, 1980
SINVISION LINEAR ARRAY REAL TIME
K800653 · DXK
Kt Medical, Inc.
Cardiovascular · 119d
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