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
74137–74160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2002
COOPERSURGICAL TRIAL TRANSFER CATHETER
K023384 · MQF
Cooper Surgical
Obstetrics & Gynecology · 66d
Cleared Dec 13, 2002
SPERMGRAD, MODELS 10022/10063
K023403 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466 · ELW
Cavex Holland BV
Dental · 58d
Cleared Dec 13, 2002
BIOLOY
K023477 · EJH
Neirynck & Vogt NV
Dental · 58d
Cleared Dec 13, 2002
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K023491 · FRN
Help Technologies
General Hospital · 57d
Cleared Dec 13, 2002
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
K023500 · FLL
Innovatech, Inc.
General Hospital · 56d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d
Cleared Dec 13, 2002
ENHANCE HTF MEDIUM WITH HEPES
K023655 · MQL
Conception Technologies
Obstetrics & Gynecology · 44d
Cleared Dec 13, 2002
SPERM WASH MEDIUM WITH GENTAMICIN
K023717 · MQL
Conception Technologies
Obstetrics & Gynecology · 38d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Aesculap, Inc.
Orthopedic · 30d
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 13, 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · FRN
I-Flow Corp.
General Hospital · 25d
Cleared Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853 · DFC
Kamiya Biomedical Co.
Immunology · 24d
Cleared Dec 13, 2002
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K023938 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 17d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Omron Healthcare, Inc.
Cardiovascular · 204d
Cleared Dec 12, 2002
GEBAUER'S INSTANT ICE
K021726 · MLY
Gebauer Co.
Physical Medicine · 202d
Cleared Dec 12, 2002
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
K023051 · LKF
Prosurg, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 12, 2002
UNIDUS MALE LATEX CONDOM
K023059 · HIS
Unidus Corp.
Obstetrics & Gynecology · 90d
Cleared Dec 12, 2002
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16,...
K023147 · IKN
Bortec Biomedical, Ltd.
Neurology · 83d
Cleared Dec 12, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K023180 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317 · DJR
Lin-Zhi International, Inc.
Toxicology · 70d