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
165769–165792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · CBK
Healthdyne, Inc.
Anesthesiology · 59d
Cleared Dec 18, 1980
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
K802586 · JXG
American Heyer Schulte
Neurology · 59d
Cleared Dec 18, 1980
ENDOTRACHEAL TUBE HOLDER
K802601 · CBH
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 58d
Cleared Dec 18, 1980
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 50d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 2132V
K802729 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE AP2132V
K802732 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE AP2090V
K802733 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 710
K802734 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 740AP
K802735 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COOLECTION BAG TYPE 2090V
K802736 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 1590V
K802737 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 1505V
K802738 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 710AP
K802739 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
LOMATUELL OINTMENT DRESSING
K802793 · NAE
Secol Co.
General & Plastic Surgery · 44d
Cleared Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · KPF
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Dec 18, 1980
DIGOXIN RADIOIMMUNOASSAY KIT
K802841 · DNL
American Diagnostic Corp.
Toxicology · 36d
Cleared Dec 18, 1980
SINGLE VIAL LIPASE TEST KIT
K802842 · CHI
Biodynamics Corp.
Chemistry · 36d
Cleared Dec 18, 1980
CLEANSER, ROOT CANAL
K802853 · KJJ
Dentsply Intl.
Dental · 35d
Cleared Dec 18, 1980
SAFE T COUNT
K802865 · KDC
Instranetics, Inc.
General & Plastic Surgery · 36d
Cleared Dec 17, 1980
THE VITA 2 DISPOSABLE DIALYZER
K801634 · FHS
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 155d
Cleared Dec 17, 1980
LEWIS TRAPEZO METACARPAL PROSTHESIS
K802106
Howmedica Corp.
Orthopedic · 105d
Cleared Dec 17, 1980
F110 PHOTO BINOCULAR OPHTHALMOSCOPE
K802351 · HLG
Minami, Tomine & Lew
Ophthalmic · 83d
Cleared Dec 17, 1980
METRICON #120 FLUOROPHOTOMETER
K802355 · HJO
Metricon, Ltd.
Ophthalmic · 83d
Cleared Dec 17, 1980
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.
K802381 · HQC
Fibra Sonics, Inc.
Ophthalmic · 79d