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
146737–146760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1985
REFLOTRON SYSTEM
K852133 · JJE
Boehringer Mannheim Corp.
Chemistry · 123d
Cleared Sep 16, 1985
STERILIZATION CONTAINER
K852335 · FRG
Bemis Mfg. Co.
General Hospital · 108d
Cleared Sep 16, 1985
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · KRI
Gambro, Inc.
Cardiovascular · 98d
Cleared Sep 16, 1985
SAF-D-FIB
K852469 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 95d
Cleared Sep 16, 1985
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · LFZ
Behring Diagnostics, Inc.
Microbiology · 97d
Cleared Sep 16, 1985
CMV-IHA
K852494 · LJO
Hillcrest Biologicals
Microbiology · 96d
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · LDF
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Sep 16, 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · LJP
Syva Co.
Microbiology · 77d
Cleared Sep 16, 1985
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K852797 · LDF
Mansfield Scientific, Inc.
Cardiovascular · 80d
Cleared Sep 16, 1985
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
K852799 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 77d
Cleared Sep 16, 1985
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)
K852808 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 76d
Cleared Sep 16, 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · DTB
Telectronics, Inc.
Cardiovascular · 63d
Cleared Sep 16, 1985
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127 · CDD
Micromedic Systems
Chemistry · 53d
Cleared Sep 16, 1985
PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP
K853205
Depuy, Inc.
Orthopedic · 47d
Cleared Sep 16, 1985
ACCU-FLO PRESSURE VALVE
K853215 · JXG
Codman & Shurtleff, Inc.
Neurology · 46d
Cleared Sep 16, 1985
PRECEPT CEFTRIAXONE
K853273 · LTW
Austin Biological Laboratories
Microbiology · 42d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN G REAGENT
K853465 · DEW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C3 COMPLEMENT REAGENT
K853466 · CZW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN A REAGENT
K853467 · CZP
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C4 COMPLEMENT REAGENT
K853468 · DBI
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN M REAGENT
K853469 · DFT
Gilford
Immunology · 28d
Cleared Sep 16, 1985
ALCOHOL CALIBRATORS
K853532 · DNN
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
ABSORBANCE TEST SOLUTION
K853533 · JIT
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · LAN
American Dade
Chemistry · 21d