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
173713–173736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1977
ARTIUS SYSTEM
K771151 · HGL
General Electric Co.
Obstetrics & Gynecology · 41d
Cleared Aug 04, 1977
ANTI-MITOCHONDRIAL
K771155 · DBE
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Aug 04, 1977
ANESTHESIA RESPIRATOR
K771217 · BZD
Rule Medical Instruments, Inc.
Anesthesiology · 30d
Cleared Aug 04, 1977
BRONCHO-CATH
K771219 · BTS
Mallinckrodt Critical Care
Anesthesiology · 30d
Cleared Aug 04, 1977
T3 RIA TEST SYSTEM
K771220 · CDP
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
T4 RIA TEST SYSTEM
K771221 · CDX
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
TSH RIA TEST SYSTEM
K771222 · JLW
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
EMERGENCY OXYGEN RESUSCITATOR
K771299 · BTL
Fraser Sweatman, Inc.
Anesthesiology · 21d
Cleared Aug 04, 1977
DIGITAL RADIATION DETECTOR
K771301 · IZD
Actus, Inc.
Radiology · 20d
Cleared Aug 04, 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · GIM
Organon, Inc.
Hematology · 21d
Cleared Aug 04, 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · GIM
Organon, Inc.
Hematology · 21d
Cleared Aug 04, 1977
BAIN BREATHING CIRCUIT
K771307 · CAI
Respiratory Care, Inc.
Anesthesiology · 17d
Cleared Aug 04, 1977
BICHROMATIC ANALYZER ABA-200
K771345 · JJE
Abbott Laboratories
Chemistry · 15d
Cleared Aug 04, 1977
ECG SCOPE MODEL 7833
K771360 · DRT
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Aug 04, 1977
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A
K771361 · DRS
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Aug 04, 1977
PORTABLE INFANT VENTILATOR
K771368 · FOC
Cavitron Corp.
Gastroenterology & Urology · 10d
Cleared Aug 04, 1977
SCREENING COMPUTEO SC-20
K771371 · BZM
Cavitron Corp.
Anesthesiology · 10d
Cleared Aug 04, 1977
SYSTEM II
K771372 · DSF
Irex Corp.
Cardiovascular · 10d
Cleared Aug 04, 1977
SCANNER TREND SYSTEM
K771374 · DSI
Instruments For Cardiac Research
Cardiovascular · 10d
Cleared Aug 04, 1977
2 JET SET
K771385 · BYF
Bd Becton Dickinson Vacutainer...
Anesthesiology · 8d
Cleared Aug 04, 1977
LUNG VOLUME & PRESSURE MONITOR
K771407 · BZQ
Research Development Corp.
Anesthesiology · 6d
Cleared Aug 04, 1977
WROUGHT (FORGED) VITALLIUM
K771408 · LZN
Howmedica Corp.
Orthopedic · 6d
Cleared Aug 04, 1977
PREGELLED DISP. EKG MONITORING ELECT-
K771447 · DRX
Hayes Products, Inc.
Cardiovascular · 2d
Cleared Aug 03, 1977
X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC
K770693 · IZH
Xonics Medical Systems, Inc.
Radiology · 112d