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
161113–161136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1982
ANESTHECACHE
K821307 · BRY
Med-Life, Inc.
Anesthesiology · 10d
Cleared May 14, 1982
MODIFIED NEURO SURGERY NIBBLING FORCEPS
K821357 · HAO
Downs Surgical , Ltd.
Neurology · 8d
Cleared May 13, 1982
CURITY ECONOMY II CYSTOSCOPY TRAY
K820851 · FAJ
The Kendal Co.
Gastroenterology & Urology · 48d
Cleared May 13, 1982
SPENCO CRYOPRESS
K820906 · IMD
Spenco Medical Corp.
Physical Medicine · 42d
Cleared May 13, 1982
DIGILOG SYSTEM
K820958
Medical Design Laboratories, Inc.
Orthopedic · 37d
Cleared May 13, 1982
FOLEY INSERTION TRAYS W/OVERWRAY
K820987 · KOD
Inmed Corp.
Gastroenterology & Urology · 36d
Cleared May 13, 1982
ABSORB FURN SHEET
K820994 · FPY
American Convertors Div., American...
General & Plastic Surgery · 35d
Cleared May 13, 1982
MULTICLIP DISP. LIGATING CLIP DEVICE
K820999 · FZP
Davis & Geck, Inc.
General & Plastic Surgery · 35d
Cleared May 13, 1982
LIQUIFILM WETTING SOLUTION
K821051 · HPX
Allergan, Inc.
Ophthalmic · 28d
Cleared May 13, 1982
SOAKARE
K821052 · HPX
Allergan, Inc.
Ophthalmic · 28d
Cleared May 13, 1982
TOTAL
K821054 · HPX
Allergan, Inc.
Ophthalmic · 28d
Cleared May 13, 1982
MERITECASTREP (TM)
K821100 · GTZ
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared May 13, 1982
BI PLATE-XLD/HEKTOEN #30012
K821108 · JSI
Biomedia, Inc.
Microbiology · 23d
Cleared May 13, 1982
DISPOSABLE THERMOPLASTIC RUBBER MOUTH
K821128 · BYP
Airlife, Inc.
Anesthesiology · 23d
Cleared May 13, 1982
MODEL 28C HEAPING AID
K821132 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 23d
Cleared May 13, 1982
TDX TM STREPTOMYCIN
K821136 · LEH
Abbott Laboratories
Hematology · 23d
Cleared May 13, 1982
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141 · CDX
Immunotech Corp.
Immunology · 22d
Cleared May 13, 1982
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
K821154 · KLS
Jay Rau, Technical Suppprt
Chemistry · 17d
Cleared May 13, 1982
KOLOR KODE TM
K821166 · KDC
Devon Industries, Inc.
General & Plastic Surgery · 17d
Cleared May 13, 1982
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
K821181 · EQN
Machida America, Inc.
Ear, Nose, Throat · 16d
Cleared May 13, 1982
MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-
K821182 · EQN
Machida America, Inc.
Ear, Nose, Throat · 16d
Cleared May 13, 1982
STER-O-MIST 1000 ML
K821191 · CAF
Inhalation Therapy Equipment, Co.
Anesthesiology · 16d
Cleared May 13, 1982
DESERET OFFSET PRN ADAPTER
K821245 · KGZ
Warner-Lambert Co.
General & Plastic Surgery · 14d
Cleared May 12, 1982
FETALSCREEN
K820199
Ortho Diagnostic Systems, Inc.
Hematology · 106d