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
156433–156456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1983
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K832217 · DHB
Ventrex Laboratories, Inc.
Chemistry · 104d
Cleared Sep 20, 1983
ALLERGEN CONTROL INHALENT
K832218 · DGC
Ventrex Laboratories, Inc.
Chemistry · 104d
Cleared Sep 20, 1983
HBO-1 PASS-THROUGH/EXTENSION TUBE
K832434 · FPA
Nauset Labs
General Hospital · 60d
Cleared Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
K832449 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 57d
Cleared Sep 20, 1983
ELEVATOR CUSHION
K832472 · FWZ
Inmed Corp.
General & Plastic Surgery · 56d
Cleared Sep 20, 1983
SCLERAL BUCKLING IMPLANTS DIF/TYPES
K832481 · HQX
Storz Instrument Co.
Ophthalmic · 56d
Cleared Sep 20, 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 55d
Cleared Sep 20, 1983
SODIUM TEST KIT
K832552 · CEI
Mallinckrodt Critical Care
Chemistry · 50d
Cleared Sep 20, 1983
POTASSIUM TEST KIT
K832553 · CEJ
Mallinckrodt Critical Care
Chemistry · 50d
Cleared Sep 20, 1983
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · KRJ
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Sep 20, 1983
EARLY IN HOME PREGNANCY TEST
K832599 · JHJ
Warner-Lambert Co.
Chemistry · 49d
Cleared Sep 20, 1983
INTUBATION KIT
K832629 · BTR
Calbio, Inc.
Anesthesiology · 47d
Cleared Sep 20, 1983
BIOSPAL 3000 S
K832645 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 46d
Cleared Sep 20, 1983
ACCLAIM
K832648 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 46d
Cleared Sep 20, 1983
BIOSPAL 1200S
K832659 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 43d
Cleared Sep 20, 1983
WHEELCHAIR-VARIOUS MODELS
K832685 · IOR
Health America
Physical Medicine · 49d
Cleared Sep 20, 1983
RISER STANDUP WHEELCHAIR
K832696 · IPL
Imex Medical Systems, Inc.
Physical Medicine · 41d
Cleared Sep 20, 1983
DUAL DIAL VENTURI STYLE MASK
K832725 · BYF
Airlife, Inc.
Anesthesiology · 39d
Cleared Sep 20, 1983
MOBIE
K832727 · INI
Everest & Jennings, Inc.
Physical Medicine · 39d
Cleared Sep 20, 1983
FEMORAL FRACTURE ORTHOSIS
K832740
Orthomedics
Orthopedic · 36d
Cleared Sep 20, 1983
JASON CERVICAL ORTHOSIS
K832741 · IQF
Orthomedics
Physical Medicine · 36d
Cleared Sep 20, 1983
EXTENSION CONTROL KNEE ORTHOSIS
K832742 · ITM
Orthomedics
Physical Medicine · 36d
Cleared Sep 20, 1983
OC3 FLYER
K832745 · ITI
Intl. Medical Equipment Corp.
Physical Medicine · 36d
Cleared Sep 20, 1983
S & W SW52E W/POWER BACK LIFT
K832768 · LGX
S & W Enterprises, Inc.
General Hospital · 35d