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

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176,076 results
165361–165384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1981
ARTUS DRILL #6000
K803288 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #4000
K803289 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #3000
K803290 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #2000
K803291 · DZI
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
GUARDIAN PEEL POUCHES
K803293 · FRG
Kimberly-Clark Corp.
General Hospital · 29d
Cleared Jan 28, 1981
ORTHODONTIC ELASTICS
K810010 · ECI
Orec Corp.
Dental · 23d
Cleared Jan 28, 1981
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
K810011 · KLB
Alpha Gamma Laboratory
Toxicology · 23d
Cleared Jan 28, 1981
DENTAL ENDODONTIC CEMENT
K810026 · EMA
Witech Laboratory
Dental · 23d
Cleared Jan 28, 1981
MIC-2000 INOCULUM TRAY LID
K810039 · JTC
Dynatech Corp.
Microbiology · 19d
Cleared Jan 28, 1981
BACTEC BACTERIAL DETECTION SYSTEM: #5
K810042 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 28, 1981
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K810053 · KGX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 16d
Cleared Jan 28, 1981
RICA (DIAGNOSTIC INSTRUMENTS)
K810054 · GWZ
Robert I. Chien & Assoc., Inc.
Neurology · 16d
Cleared Jan 28, 1981
SCOTT CM42 PASTEURIZER
K810065 · HGX
William Harvey Life Products Corp.
Obstetrics & Gynecology · 15d
Cleared Jan 28, 1981
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 15d
Cleared Jan 28, 1981
LDH-L LIQUID ENZYMATIC, KINETIC KIT
K810083 · CFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON KIT
K810085 · CFM
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON & TICB
K810086 · JQF
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088 · CDH
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
MODEL 2 FLOWMETER
K810132 · CAN
Harris Calorific
Anesthesiology · 9d
Cleared Jan 28, 1981
TAMPAX MAXITHINS PADS
K810160 · HHD
Tampax, Inc.
Obstetrics & Gynecology · 6d
Cleared Jan 26, 1981
DEPILATOR, DERMA-I & DERMA-II
K770791 · KCX
Electro-Kinetic Eng/Mfg
General & Plastic Surgery · 1365d
Cleared Jan 26, 1981
AMES SERA-PAK HEMOGLOBIN REAGENT
K803248 · KHG
Miles Laboratories, Inc.
Hematology · 34d
Cleared Jan 26, 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · DFT
Icl Scientific
Immunology · 34d
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · DFZ
Icl Scientific
Immunology · 28d