FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
156457–156480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 1983
PREFILLED IEC COLUMNS
K831289 · DJY
Berwick Medical Products, Inc.
Toxicology · 57d
Cleared Jun 16, 1983
HEMACAL
K831306 · KRZ
Hematology Marketing Assoc.
Hematology · 55d
Cleared Jun 16, 1983
VASCULAB BLOOD PRESSURE CUFF
K831393 · DXQ
Medasonics, Inc.
Cardiovascular · 48d
Cleared Jun 16, 1983
COLORIMETRIC BUN
K831414 · CDL
Bio-Analytics Laboratories, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
LACTIC DEHYDROGENASE REAGENT SET
K831415 · CFJ
Sterling Biochemical, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
EMIT QST TOBRAMYCIN CONTROL
K831417 · LAS
Syva Co.
Toxicology · 44d