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
170881–170904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1979
CONTROL SET, EMIT METHOTREXATE
K781827 · LAS
Syva Co.
Toxicology · 65d
Cleared Jan 03, 1979
TEST SET, 125 I-DIGOXIN
K781834 · DNL
Wien Laboratories, Inc.
Toxicology · 65d
Cleared Jan 03, 1979
RIA, QUANTIMUNE E3
K781850 · CGI
Bio-Rad
Chemistry · 62d
Cleared Jan 03, 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · KHQ
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Jan 03, 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · CIG
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 03, 1979
ANALYSIS SYSTEM, PREP SAMPLE
K781941 · DOZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 44d
Cleared Jan 03, 1979
BLOOD GAS SYSTEM MODEL 168
K781968 · CHL
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
BLOOD, HEMATOLOGY REFERENCE CONTROL
K781969 · JPK
Coulter Electronics, Inc.
Hematology · 40d
Cleared Jan 03, 1979
CHOLESTEROL REAGENT SUBSTRATE SET
K781970 · JHO
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
ACID REAGENT, URIC SINGLE VIAL
K781996 · CDO
Calbiochem-Behring Corp.
Chemistry · 35d
Cleared Jan 03, 1979
ROTARY SCALER
K782007 · ELB
Star Dental Mfg. Co.
Dental · 33d
Cleared Jan 03, 1979
FIAX TEST KIT
K782041 · DHN
Idt, A Division of Whittaker M.A....
Immunology · 27d
Cleared Jan 03, 1979
PRINTER, TEK PRO TEK TALLY II
K782050 · GKZ
Tekpro
Hematology · 26d
Cleared Jan 03, 1979
EXETRELUT
K782066 · KEA
Mcb Manufacturing Chemists, Inc.
Toxicology · 21d
Cleared Jan 03, 1979
DILATOR, MIZUTANI LAMINARIA TENT
K782067 · HDY
British Marketing Ent., Ltd.
Obstetrics & Gynecology · 21d
Cleared Jan 03, 1979
VAGATEX
K782083 · HIR
Vagatex
Gastroenterology & Urology · 20d
Cleared Jan 03, 1979
HYCEL COUNTER 333
K782100 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 222
K782101 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 211
K782102 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
PASTE, PRO CARE PROPHYLAXIS
K782104 · FZE
Young Dental Manufacturing Co. 1, LLC
General & Plastic Surgery · 15d
Cleared Jan 02, 1979
DIFFUSION OPTION, OMNI-LAB
K781871 · CCJ
Ohio Medical Products
Anesthesiology · 60d
Cleared Jan 02, 1979
GENERATOR, BIOTEC 876 PULSE
K790031
Biomagnetic Technologies, Inc.
Cardiovascular
Cleared Dec 29, 1978
BETA-TEC
K781794 · JHI
Wampole Laboratories
Immunology · 65d
Cleared Dec 29, 1978
LIGHT, INSIDE
K781878 · EAY
Midwest
Dental · 53d