FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84745–84768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1999
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
K992692 · LPL
Benz Research and Development Corp.
Ophthalmic · 68d
Cleared Oct 18, 1999
INSURE PRO TEST
K992695 · JHI
Inbios Intl., Inc.
Chemistry · 68d
Cleared Oct 18, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K992723 · CAC
Transfusion Technologies Corp.
Anesthesiology · 66d
Cleared Oct 18, 1999
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL...
K992766 · MRR
Genzyme Corp.
Chemistry · 62d
Cleared Oct 18, 1999
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT,...
K992845 · JIX
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
HICHEM TOTAL PROTEIN REAGENT
K992846 · CEK
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
REP CHOLESTEROL PROFILE KIT
K992971 · JHO
Helena Laboratories
Chemistry · 45d
Cleared Oct 18, 1999
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 25d
Cleared Oct 15, 1999
DAIWA MODEL 180
K983616 · DXN
Daiwa Products, Inc.
Cardiovascular · 366d
Cleared Oct 15, 1999
FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM...
K990401 · IYO
Fukuda Denshi USA, Inc.
Radiology · 248d
Cleared Oct 15, 1999
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE
K990750 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 221d
Cleared Oct 15, 1999
LUMA-CATH FIXED CURVE EP CATHETERS
K991025 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 200d
Cleared Oct 15, 1999
IRRIGATION OR INFUSION PUMP K PUMP
K991203 · FRN
Kmi Kolster Methods, Inc.
General Hospital · 190d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · HSD
Endotec, Inc.
Orthopedic · 88d
Cleared Oct 15, 1999
ACTITRAC
K992410 · GWQ
Individual Monitoring Systems, Inc.
Neurology · 87d
Cleared Oct 15, 1999
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
K992416 · LYC
Usbiomaterials Corp.
Dental · 87d
Cleared Oct 15, 1999
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K992435 · EFW
Azo Enterprises
Dental · 85d
Cleared Oct 15, 1999
KSEA SCBCOM
K992469 · FET
Karl Storz Endoscopy
Gastroenterology & Urology · 81d
Cleared Oct 15, 1999
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K992478 · DXN
Hewlett-Packard, Healthcare Solutions...
Cardiovascular · 81d
Cleared Oct 15, 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
K992511 · GKZ
Abx Diagnostics
Hematology · 80d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · GWM
Codman & Shurtleff, Inc.
Neurology · 74d
Cleared Oct 15, 1999
MODIFICATION TO INTRASTENT
K992816 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 15, 1999
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100...
K992870 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 50d
Cleared Oct 15, 1999
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
K992878 · MVM
Immco Diagnostics, Inc.
Immunology · 50d