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
156865–156888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1983
PENTAX FG-34JA GASTROFIBERSCOPE
K832007 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 49d
Cleared Aug 11, 1983
ANTI-N DNA ANTIBODY TEST KIT
K832031 · KTL
Breit Laboratories, Inc.
Immunology · 49d
Cleared Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · JIX
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Aug 11, 1983
TOTAL CO2 REAGENT SET
K832071 · CIE
American Research Products Co.
Chemistry · 45d
Cleared Aug 11, 1983
BILIRUBIN CALIBRATORS & CONTROL
K832094 · JIT
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 11, 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · DLZ
Syva Co.
Chemistry · 43d
Cleared Aug 11, 1983
EDSLAB PRESSURE GAUGE
K832323 · MAV
American Edwards Laboratories
Cardiovascular · 27d
Cleared Aug 10, 1983
UNIVERSAL CORONARY CANNULA
K831330 · DWF
Possis Medical, Inc.
Cardiovascular · 107d
Cleared Aug 10, 1983
STAT-TRAK LIQUID ELECTROLYTE CONTROL
K831389 · JJR
United Diagnostics, Inc.
Chemistry · 103d
Cleared Aug 10, 1983
FOLEY-TEMP
K831567 · KOD
Mallinckrodt Critical Care
Gastroenterology & Urology · 86d
Cleared Aug 10, 1983
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
K832003 · JJS
American Dade
Chemistry · 49d
Cleared Aug 08, 1983
INJECTION SEALING CAP 13791
K830541 · FOZ
Quinton, Inc.
General Hospital · 167d
Cleared Aug 08, 1983
MEDION MI-200 IONTOPHORETIC MEDICATOR
K831000
Etherington Industries
Dental · 132d
Cleared Aug 08, 1983
QUANTIGEN T & B CELL ASSAY
K831053 · LIZ
Bio-Rad
Chemistry · 129d
Cleared Aug 08, 1983
COMPUDIAL/KP-1
K831132 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 124d
Cleared Aug 08, 1983
CMV RQ BIO-ENZABEAD KIT
K831343 · LFZ
Litton Bionetics
Immunology · 105d
Cleared Aug 08, 1983
PRESSURE MONITOR & CONTROL UNIT APC-02A
K831402 · KXM
Parker Hannifin Corp.
Gastroenterology & Urology · 98d
Cleared Aug 08, 1983
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K831457 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 94d
Cleared Aug 08, 1983
ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
K831496
Diagnostic Reagent Tech.
Immunology · 90d
Cleared Aug 08, 1983
WASHER 6000 MICRO-C LISA SYSTEM
K831640 · JTC
Organon Teknika Corp.
Chemistry · 77d
Cleared Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 08, 1983
LEGIONELLA IFA KIT I
K831760 · LHL
Bionetic Laboratory Products
Toxicology · 68d
Cleared Aug 08, 1983
URINE BAG SYSTEM
K831796 · KNX
I M, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 08, 1983
PNEUMATIC/ELECTRIC/HYDRAULIC BED
K831821 · FNL
G.W. Healthcare, Inc.
General Hospital · 63d