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
168577–168600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1979
AMBU PAEDI ANAESTHESIA SYSTEM
K792499 · CAI
Narco Air-Shields
Anesthesiology · 15d
Cleared Dec 19, 1979
MINI-H-FIXATION
K792561 · JEC
Geny Medical, Inc.
Orthopedic · 7d
Cleared Dec 19, 1979
MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR
K792564 · CBK
Eastern Anesthesia, Inc.
Anesthesiology · 7d
Cleared Dec 19, 1979
COUNTER UNIT
K792571 · BWF
Empire Plastics Manufacturer
Anesthesiology · 6d
Cleared Dec 19, 1979
EMPIRE SPIROMETER
K792572 · BZK
Empire Plastics Manufacturer
Anesthesiology · 6d
Cleared Dec 19, 1979
CASTROVIEJO VASCULAR SCISSORS
K792576 · DWS
Edward Weck, Inc.
Cardiovascular · 6d
Cleared Dec 19, 1979
PACEMAKER PROGRAMMER
K792580 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 5d
Cleared Dec 18, 1979
SHILEY LOW PRESSURE THIN-CUFFED TRACH.
K792222 · EQN
Shiley, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 18, 1979
HEARING AID, UNITRON MODEL 905H
K792236 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Dec 18, 1979
AMIKACIN CONTROL SERUM
K792259 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
AMIKACIN LIQUID CONTROL SERUM
K792260 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
GENTAMICIN CONTROL SERUM
K792261 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
GENTAMICIN LIQUID CONTROL SERUM
K792262 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN CONTROL SERUM
K792263 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN LIQUID CONTROL SERUM
K792264 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
LIPASE TEST KIT
K792289 · CET
Mallinckrodt Critical Care
Chemistry · 35d
Cleared Dec 18, 1979
TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
K792316 · GEE
Ursus Konsult AB
General & Plastic Surgery · 32d
Cleared Dec 18, 1979
STATTEK BUN
K792328 · CDN
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Dec 18, 1979
BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH
K792334 · ESD
Danavox, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 18, 1979
DIATHERMIC SNARE (CRESENT TYPE)
K792343 · GEI
Mill-Rose Laboratory
General & Plastic Surgery · 29d
Cleared Dec 18, 1979
STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
K792357 · KKX
Alba-Waldensian, Inc.
General Hospital · 27d
Cleared Dec 18, 1979
FERRITIN RADIOIMMUNOASSAY
K792442 · DBF
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 19d
Cleared Dec 18, 1979
CONNECTICUT DIAGNOSTICS, LTS. DIRECT
K792465 · CIG
Connecticut Diagnostics, Ltd.
Chemistry · 15d
Cleared Dec 18, 1979
STAINS, COUNTERSTAINS & GEN. PURPOSE
K792483 · ICL
Laboratory Products, Inc.
Pathology · 29d