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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
145249–145272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1986
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
K855147 · DXY
Medtronic Vascular
Cardiovascular · 83d
Cleared Mar 17, 1986
LEECO TESTOSTERONE DIAGNOSTIC KIT
K860003 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 74d
Cleared Mar 17, 1986
MODEL 353C HEARING AID
K860035 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 17, 1986
TSH-IRMA COAT-A-COUNT KIT
K860054 · JLW
Diagnostic Products Corp.
Chemistry · 70d
Cleared Mar 17, 1986
GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)
K860119 · EJS
Deringer-Ney, Inc.
Dental · 63d
Cleared Mar 17, 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · ELW
Dentsply Intl.
Dental · 61d
Cleared Mar 17, 1986
ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
K860192 · HET
Endotherapeutics
Obstetrics & Gynecology · 54d
Cleared Mar 17, 1986
SERIES 410 LC PUMP
K860197 · KZR
The Perkin-Elmer Corp.
Toxicology · 54d
Cleared Mar 17, 1986
TOTAL BILIRUBIN REAGENT SET
K860214 · CIG
Sterling Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 17, 1986
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
K860217 · EJH
Austenal Dental, Inc.
Dental · 54d
Cleared Mar 17, 1986
REALOR ALLOY
K860299 · EJS
Degussa Dental, Inc.
Dental · 48d
Cleared Mar 17, 1986
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K860308 · CEP
Boots-Celltech Diagnostics, Inc.
Chemistry · 48d
Cleared Mar 17, 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · HGL
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 48d
Cleared Mar 17, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
K860348 · JPZ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 17, 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · JJY
American Dade
Chemistry · 46d
Cleared Mar 17, 1986
PHENOBARBITAL TEST SYSTEM
K860365 · DLZ
Allied Instrumentation Laboratory
Toxicology · 42d
Cleared Mar 17, 1986
A-GENT LIQUID ALBUMIN
K860423 · CJW
Abbott Laboratories
Chemistry · 41d
Cleared Mar 17, 1986
PARTIAL DENTURE ALLOY
K860437 · EJH
Dentsply Intl.
Dental · 41d
Cleared Mar 17, 1986
TELESTAR I, HEARING AID
K860512 · ESD
The Florida Hearing Aid Service
Ear, Nose, Throat · 34d
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Mar 17, 1986
SANDARE BCG ALBUMIN PROCEDURE
K860684 · CIX
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Mar 17, 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · CDT
Catachem, Inc.
Chemistry · 20d
Cleared Mar 17, 1986
ROOT CANAL ORGANIZER
K860817 · EIK
Pacific Union Dental, Inc.
Dental · 13d
Cleared Mar 15, 1986
NON-ABSORBENT DRAPES & ABSORBENT TOWELS
K850960 · KKX
Excel Health Care Products
General Hospital · 372d