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
157729–157752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1983
OPTISON ULTRASONIC SCALER
K837382
Pelton & Crane Co.
Radiology · 63d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · JZJ
Abbott Laboratories
Hematology · 380d
Cleared May 05, 1983
MEDIGROUP LG-102 LIGHT GUIDE
K823293 · HET
Medigroup
Obstetrics & Gynecology · 181d
Cleared May 05, 1983
VARICELISA TEST KIT
K823805 · LFY
M.A. Bioproducts
Microbiology · 139d
Cleared May 05, 1983
DIAGNON FERRITIN 125 I RIA KIT
K830580 · DBF
Iagnon Corp.
Microbiology · 71d
Cleared May 05, 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 59d
Cleared May 05, 1983
URINARY DIVERSION STENT
K830803 · LJE
Van-Tec, Inc.
Gastroenterology & Urology · 52d
Cleared May 05, 1983
LA-HISTO ANTIBODY SYSTEM #HL 1001
K830837 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared May 05, 1983
HELENA BIOSTRIP PH
K830979 · CEN
Helena Laboratories
Chemistry · 37d
Cleared May 05, 1983
DIAGNOSTICS PO2 ELECTRODE CLEANER
K831010 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 05, 1983
BATH CLEAR
K831016 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 05, 1983
API ANAIDENT
K831032 · JSP
Analytical Products, Inc.
Microbiology · 36d
Cleared May 05, 1983
BTC URINE LCG ASSAY
K831125 · JHJ
Btc Diagnostics, Inc.
Immunology · 30d
Cleared May 04, 1983
CULUTURE SET CHLAMYDIA ISOLATION AND
K830342 · LKI
Immulok, Inc.
Microbiology · 92d
Cleared May 04, 1983
BOO-BOO STRIP
K830640 · FRO
Colossus Corp.
General & Plastic Surgery · 64d
Cleared May 04, 1983
LABILE REMOVING HEMOLYZING REAGENT
K830804 · JBD
Corning Medical & Scientific
Hematology · 51d
Cleared May 04, 1983
FLOW-PAC SGOT REAGENT
K830958 · CIT
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
FLOW-PAC SGPT REAGENT
K830959 · CKA
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962 · DPO
Immuchem Corp.
Chemistry · 37d
Cleared May 04, 1983
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
K830964 · JSP
Bd Becton Dickinson Vacutainer...
Microbiology · 37d
Cleared May 04, 1983
PLAN A LIFE
K830975 · JIN
New Directions Co.
Chemistry · 40d
Cleared May 04, 1983
HELENA BIOSTRIP K
K830976 · JIN
Helena Laboratories
Chemistry · 36d
Cleared May 04, 1983
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT
K831100 · DBM
Medical Diagnostics, Ca.
Immunology · 29d
Cleared May 03, 1983
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
K830923 · BZO
Cygnus Research Corp.
Anesthesiology · 42d