FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160273–160296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 12, 1982
SIMUL-FER SERUM IRON TEST KIT
K820253 · JJA
Diagnostic Reagents, Inc.
Chemistry · 103d
Cleared May 12, 1982
MEZLIN DIAGNOSTIC REAGENT
K820578 · JTT
Miles Pharmaceuticals
Microbiology · 70d
Cleared May 12, 1982
GAMMA FETAL BLEED SCREENING TEST
K820647 · LIM
Gamma Biologicals, Inc.
Hematology · 64d
Cleared May 12, 1982
THE ICR KNEE
K820719
American Ortomed Corp.
Orthopedic · 57d
Cleared May 12, 1982
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K820731 · JPK
Fisher Scientific Co., LLC
Hematology · 56d
Cleared May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772 · JJX
Helena Laboratories
Chemistry · 50d