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
157297–157320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1983
YELLOW IRIS TM
K830220 · KQO
Intl. Remote Imaging Systems
Pathology · 144d
Cleared Jun 17, 1983
URETERAL STONE EXTRACTOR CATHETER
K831244 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 60d
Cleared Jun 17, 1983
DEMAND ANALYZER SYSTEM
K831477 · JJE
Worthington Diagnostic Systems
Chemistry · 39d
Cleared Jun 17, 1983
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
K831499 · JIN
Laprol Scientific, Inc.
Chemistry · 37d
Cleared Jun 17, 1983
PARAMAX AMALINE REAGENT
K831536 · JFJ
American Dade
Chemistry · 39d
Cleared Jun 17, 1983
GONORRHEA TRANSETTE 1 & 3
K831579 · JTW
Spectrum Diagnostic, Inc.
Immunology · 31d
Cleared Jun 17, 1983
PARAFFIN INFILTRATION MEDIUM
K831580 · KEO
Surgipath Medical Industries, Inc.
Pathology · 31d
Cleared Jun 17, 1983
FIAX IGG TEST KIT
K831609 · DGK
Intl. Diagnostic Technology
Immunology · 30d
Cleared Jun 17, 1983
SPECTRUM-10
K831655 · JSZ
Austin Biological Laboratories
Microbiology · 25d
Cleared Jun 16, 1983
UNIVERSAL CANNULA
K830719 · GCJ
Acufex Microsurgical, Inc.
General & Plastic Surgery · 100d
Cleared Jun 16, 1983
GRAF MENISCAL SUTURE SET
K830720 · FZX
Acufex Microsurgical, Inc.
General & Plastic Surgery · 100d
Cleared Jun 16, 1983
NEEDLE GUIDE MODEL 21285A
K830753 · LFL
Hewlett-Packard Co.
General & Plastic Surgery · 98d
Cleared Jun 16, 1983
PATIENT GUIDED ELBOW & SHOULDER EXERC
K830793 · BXB
Richard'S Medical Equip., Inc.
Physical Medicine · 94d
Cleared Jun 16, 1983
AUTOMATED BLOOD CELL SEPARATOR
K830831 · LKN
Cryosan, Inc.
Hematology · 92d
Cleared Jun 16, 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · LCP
Bio-Rad
Hematology · 84d
Cleared Jun 16, 1983
RAPID IDENTIFI-METHOD NEISSERIA KIT
K830968 · JTO
Austin Biological Laboratories
Microbiology · 80d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831018 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
PH 6.838 REF. BUFFER
K831019 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831021 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYTE PO2 FOR OXYGEN ELECTRODES
K831024 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYLE CARBON DIOXIDE ELECTRODES
K831025 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
BREATHING ZONE
K831067 · FRF
Upper Four, Inc.
General Hospital · 73d
Cleared Jun 16, 1983
DAC-CEL PTH KIT RD51
K831069 · CEW
Wellcome Diagnostics
Chemistry · 73d
Cleared Jun 16, 1983
DOMINION
K831098 · EJT
Unitek Corp.
Dental · 73d