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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147097–147120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1985
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K853382 · HQE
Mentor O & O, Inc.
Ophthalmic · 53d
Cleared Oct 04, 1985
RIGID ENDOSCOPE
K853514 · GCM
American Edwards Laboratories
Gastroenterology & Urology · 43d
Cleared Oct 04, 1985
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · FDX
E-Z-Em, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 04, 1985
TRAVENOL CAPD Y SET 5C4354
K853550 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 39d
Cleared Oct 04, 1985
VENTREZYME T3 IMMUNOASSAY T3
K853703 · CDP
Vxr, Inc.
Chemistry · 30d
Cleared Oct 04, 1985
COLORADO MEDICAL MODEL CTM-3000
K853735 · FIZ
Colorado Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 04, 1985
C-TERMINAL PTH RIA KIT
K853784 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 25d
Cleared Oct 04, 1985
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
K853789 · JPA
Hemotec, Inc.
Hematology · 24d
Cleared Oct 04, 1985
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
K853790 · HQY
Rocky Mountain Medical Corp.
Ophthalmic · 24d
Cleared Oct 04, 1985
LYTENING 1
K853832 · JGS
Amdev, Inc.
Chemistry · 21d
Cleared Oct 04, 1985
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
K853867 · JKC
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 17d
Cleared Oct 04, 1985
QCA ENZYMATIC CHOLESTEROL
K853871 · CHH
Bd Becton Dickinson Vacutainer...
Chemistry · 17d
Cleared Oct 04, 1985
INDIRECT OPHTHALMOSCOPE
K853891 · HLJ
Carl Zeiss, Inc.
Ophthalmic · 15d
Cleared Oct 04, 1985
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)
K853906 · JJY
Biodiagnostic Intl
Chemistry · 14d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
K853931 · JJY
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · DIF
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 03, 1985
BETA SCAN TRENDS METER
K851822 · CGA
Orange Medical Instruments, Inc.
Chemistry · 160d
Cleared Oct 03, 1985
PHASE II B-12/FOLATE KIT
K853224 · CDD
Medical & Scientific Designs, Inc.
Chemistry · 63d
Cleared Oct 03, 1985
PREGNA/TEST
K853269 · LCX
Modern Diagnostics, Inc.
Chemistry · 59d
Cleared Oct 03, 1985
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC
K853853 · JGJ
Technicon Instruments Corp.
Chemistry · 17d
Cleared Oct 02, 1985
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K851517 · DSI
Circadian, Inc.
Cardiovascular · 170d
Cleared Oct 02, 1985
PARA CON TM
K853715 · LKS
Para Scientific Co.
Microbiology · 28d
Cleared Oct 02, 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
K853717 · JLW
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 02, 1985
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · KPR
Victoreen, Inc.
Radiology · 23d