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
156385–156408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1983
BREATHING CIRCUIT BACTERIA FILTER
K831856 · CAH
Vital Signs, Inc.
General Hospital · 109d
Cleared Sep 26, 1983
BACTIGEN S. PNEUMONIAE
K831887 · GWC
Armkel, LLC
Microbiology · 105d
Cleared Sep 26, 1983
COLOR-EZE PRE-WASHED LAP SPONGES
K831913 · GDY
Ormed Mfg., Inc.
General & Plastic Surgery · 104d
Cleared Sep 26, 1983
VILENE COTTON GAUZE II
K831917 · EFQ
Hall-Tech
General & Plastic Surgery · 104d
Cleared Sep 26, 1983
TOXO-SCREEN DA TEST
K831930 · LLA
Bd Becton Dickinson Vacutainer...
Immunology · 103d
Cleared Sep 26, 1983
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 97d
Cleared Sep 26, 1983
TOXO IPA KIT IAN INDIRECT FLUORESCENT
K832069 · LJK
Bionetic Laboratory Products
Immunology · 91d
Cleared Sep 26, 1983
DIGIDENT ELEKTRONIC APEX LOCATOR
K832118
Ora-Muszeripari Szovetkezet
General & Plastic Surgery · 88d
Cleared Sep 26, 1983
TRAVELER NEBULIZING SYSTEM
K832220 · BTI
Medix of Florida, Inc.
Anesthesiology · 80d
Cleared Sep 26, 1983
DUPONT ISOLATOR 1.5 MICROBIAL TUBE
K832246 · LIO
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 77d
Cleared Sep 26, 1983
CERESTORE CORE MATERIAL
K832286 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 75d
Cleared Sep 26, 1983
ORAL SAFE
K832359 · JER
Great Lakes Orthodontics, Ltd.
Dental · 70d
Cleared Sep 26, 1983
ZOLLER BURNED LIP CONFORMER
K832366 · EIG
Universal Prosthetics, Inc.
Dental · 70d
Cleared Sep 26, 1983
QUANTUM II YEAST IDENT. SYSTEM
K832406 · JXC
Abbott Laboratories
Microbiology · 67d
Cleared Sep 26, 1983
SELECTRO-DISC
K832436 · JTO
Lab Ability, Inc.
Immunology · 63d
Cleared Sep 26, 1983
ARTERIAL BLOOD SAMPLING KIT
K832545 · CBT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 59d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Abbott Diagnostics
Hematology · 53d
Cleared Sep 26, 1983
HEATED GUTTA PERCHA DELIVERY SYSTEM
K832654 · EKM
Unitek Corp.
Dental · 49d
Cleared Sep 26, 1983
ECOLYZER #200/COHB ANALYZER SYS
K832655 · CCJ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 49d
Cleared Sep 26, 1983
OXYGEN CONNECTING TUBESET-RESPIRATORY
K832660 · BYX
San Diego Plastics, Inc.
Anesthesiology · 49d
Cleared Sep 26, 1983
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · BZO
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 48d
Cleared Sep 26, 1983
SKIN STAPLING DEVICE SC2000
K832709 · GDT
Prosper, Inc.
General & Plastic Surgery · 45d
Cleared Sep 26, 1983
EASYTOUCH HEMOGLOBIN REAGENT
K832750 · KHG
Worthington Diagnostic Systems
Chemistry · 42d
Cleared Sep 26, 1983
LANE ONE
K832770 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 41d