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

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175,820 results
143185–143208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1986
MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM
K863275 · HIB
Martin Medical
Obstetrics & Gynecology · 8d
Cleared Sep 02, 1986
SURGI-WIPES
K863278
Dermacare Products, Inc.
General & Plastic Surgery · 8d
Cleared Aug 29, 1986
J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS
K860678 · JYS
Jay Kenny Templeton
Ear, Nose, Throat · 185d
Cleared Aug 29, 1986
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682 · CGA
Gambro, Inc.
Chemistry · 185d
Cleared Aug 29, 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · JAK
General Electric Co.
Radiology · 116d
Cleared Aug 29, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · EWG
Laserscope
Ear, Nose, Throat · 94d
Cleared Aug 29, 1986
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119 · DYG
Parke-Davis Co.
Cardiovascular · 87d
Cleared Aug 29, 1986
OMC ORTHOMET CANNULATED SCREW
K862157
Orthomet, Inc.
Orthopedic · 85d
Cleared Aug 29, 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · HWC
Buckman Co., Inc.
Orthopedic · 79d
Cleared Aug 29, 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Aug 29, 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · DQO
Shiley, Inc.
Cardiovascular · 60d
Cleared Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · DWD
Gish Biomedical, Inc.
Cardiovascular · 58d
Cleared Aug 29, 1986
AVL MODEL 984 ELECTROLYTE ANALYZER
K862819 · JGS
Avl Scientific Corp.
Chemistry · 36d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Aug 29, 1986
NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
K862876 · KOO
Block Drug Company, Inc.
Dental · 30d
Cleared Aug 29, 1986
ALP (OPT) REAGENT
K862905 · CJE
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 29, 1986
SURGICAL VITEX
K862926 · ELE
Jeneric Ind.
Dental · 28d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 29, 1986
PERCU GUIDE I (LOOP TYPE)
K863090 · GDF
E-Z-Em, Inc.
General & Plastic Surgery · 16d
Cleared Aug 29, 1986
BICORD BY QMED
K863091 · HAM
Qmed, Inc.
General & Plastic Surgery · 16d
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 29, 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · GBS
Sheridan Catheter Corp.
General & Plastic Surgery · 14d
Cleared Aug 29, 1986
VACU-GUARD
K863162
Arbor Technologies, Inc.
General & Plastic Surgery · 11d
Cleared Aug 29, 1986
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
K863201 · GCY
Allergan, Inc.
General & Plastic Surgery · 10d