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
148033–148056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1985
QUICK-CHEM CALIBRATION SET
K852260 · JIW
Seragen Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 22, 1985
UROL-GUANT
K852295 · JJW
Dimension Diagnostics
Chemistry · 54d
Cleared Jul 22, 1985
TDX REA TRIGLYCERIDES
K852556 · JGW
Abbott Laboratories
Chemistry · 35d
Cleared Jul 22, 1985
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Jul 22, 1985
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
K852675 · JHI
Amersham Corp.
Chemistry · 28d
Cleared Jul 22, 1985
IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
K852676 · CHL
Allied Instrumentation Laboratory
Chemistry · 28d
Cleared Jul 22, 1985
SGOT/ALT REAGENT
K852783 · CIT
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
ALKALINE PHOSPHATASE
K852784 · CJE
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · CEK
American Research Products Co.
Chemistry · 17d
Cleared Jul 19, 1985
MAMMOGRAPH III
K844119 · IZH
American Medical Imports, Inc.
Radiology · 269d
Cleared Jul 19, 1985
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
K850151 · BZO
Life Products, Inc.
Anesthesiology · 185d
Cleared Jul 19, 1985
JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
K850924 · JAY
Vulcan Laboratories, Inc.
Anesthesiology · 136d
Cleared Jul 19, 1985
DIGITMATIC DM2
K851128 · JOM
Medimatic
Cardiovascular · 121d
Cleared Jul 19, 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · DXQ
Howmedica Corp.
Cardiovascular · 94d
Cleared Jul 19, 1985
PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
K851848 · LIT
Mansfield Scientific, Inc.
Cardiovascular · 84d
Cleared Jul 19, 1985
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
K851891 · LOJ
Richard Scott Elliott
Immunology · 80d
Cleared Jul 19, 1985
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · DTC
Seamed Corp.
Cardiovascular · 80d
Cleared Jul 19, 1985
REMOTE SPEED CONTROL
K851946 · ISD
Th Charters, Inc.
Physical Medicine · 77d
Cleared Jul 19, 1985
TORQUE FEEDBACK METER
K851967 · ISD
Th Charters, Inc.
Physical Medicine · 74d
Cleared Jul 19, 1985
JYROCHAIR, MODEL SK-H
K852015 · ITI
Medco Products, Co., Inc.
Physical Medicine · 71d
Cleared Jul 19, 1985
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044 · LLH
Marion Laboratories, Inc.
Microbiology · 71d
Cleared Jul 19, 1985
PRESTON LOWER LIMB CPM UNIT
K852065 · BXB
Therapeutic Equipment Corp.
Physical Medicine · 67d
Cleared Jul 19, 1985
TEMREX DENTAL POLISHING PASTE
K852157 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 63d
Cleared Jul 19, 1985
EBI FOOT MASSAGING PUMP
K852264 · IRP
Electro-Biology, Inc.
Physical Medicine · 56d