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
167953–167976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1980
PARKE-DAVIS TOTAL KNEE PROSTHESIS
K800363 · KTZ
Warner-Lambert Co.
Orthopedic · 19d
Cleared Mar 10, 1980
EARSCOPE
K800365 · ERA
Nash & Assoc.
Ear, Nose, Throat · 19d
Cleared Mar 10, 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 19d
Cleared Mar 10, 1980
ELLIK BLADDER EVACUATOR
K800397 · KQT
Sage Products, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 10, 1980
VARIOTHERM
K800442 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 10, 1980
HYGROTHERM
K800443 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 10, 1980
ESOPHAGEAL STETHESCOPE
K800463 · BZW
Medical Components, Inc.
Anesthesiology · 10d
Cleared Mar 07, 1980
FETAL MONITOR MODEL FHM-1
K800013 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 05, 1980
FIXOMULL
K792725 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 65d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
K800004 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Mar 05, 1980
SIEMENS-ELEMA AB MANUAL VENTILATION
K800114 · CBK
Siemens Elema AB
Anesthesiology · 48d
Cleared Mar 05, 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · JQP
Instrumentation Laboratory CO
Chemistry · 26d
Cleared Mar 05, 1980
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296 · GGM
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 05, 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
K800297 · CEO
Sandare Chemical Co., Inc.
Chemistry · 23d
Cleared Mar 05, 1980
AMERLEX T-4 RIA KIT
K800300 · CDX
Amersham Corp.
Chemistry · 23d
Cleared Mar 05, 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · CDT
Sigma Chemical Co.
Chemistry · 23d
Cleared Mar 05, 1980
ORTHO ANTISERA CONTROL
K800310 · KSF
Ortho Diagnostics, Inc.
Hematology · 22d
Cleared Mar 05, 1980
SURGITEK FOERSTER FACE LIFT DRAIN
K800331 · GCY
Medical Engineering Corp.
General & Plastic Surgery · 21d
Cleared Mar 05, 1980
RADIOEAR MODEL 2080 (HEARING AID)
K800332 · ESD
Radioear Corp.
Ear, Nose, Throat · 20d
Cleared Mar 05, 1980
GOLDEN RETRIEVERS OR SILVER RETRIEVERS
K800444 · HXB
Instrument Makar, Inc.
Orthopedic · 6d
Cleared Mar 05, 1980
WATER PIK TRAVELER, MODEL 79
K800448 · EFS
Teledyne, Inc.
Dental · 6d
Cleared Mar 04, 1980
GRAPHIC STRESS TELETHERMOMETRY
K800491 · IYM
Gst Laboratories of Ca, Inc.
Radiology
Cleared Mar 03, 1980
HYSTEROSER
K791330 · HIH
A. B. Vacuum Extractor, Inc.
Obstetrics & Gynecology · 229d