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
84265–84288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1999
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
K993215 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 69d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Mitek Products
Orthopedic · 64d
Cleared Dec 02, 1999
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING...
K993271 · LYY
Quality Latex Corp. Sdn Bhd
General Hospital · 63d
Cleared Dec 02, 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR...
K993457 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 50d
Cleared Dec 02, 1999
DELTAPAL, ALLOY NO. 5161
K993474 · EJS
Metalor Dental USA Corp.
Dental · 49d
Cleared Dec 02, 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50...
K993500 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 48d
Cleared Dec 02, 1999
CARESIDE ANALYZER
K993634 · JJF
Careside, Inc.
Chemistry · 36d
Cleared Dec 02, 1999
DURACON INSET PATELLA, 25MM
K993692 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 02, 1999
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · JHI
Unipath , Ltd.
Chemistry · 30d
Cleared Dec 02, 1999
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM...
K993820 · LYY
Felda Rubber Corp.
General Hospital · 20d
Cleared Dec 02, 1999
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE,...
K993944 · GEI
Rita Medical Systems
General & Plastic Surgery · 13d
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · LSL
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared Dec 01, 1999
PLATELETWORKS
K990398 · JOZ
Array Medical, Inc.
Hematology · 295d
Cleared Dec 01, 1999
CPAP/PRO CPAP INTERFACE
K992384 · BZD
Stevenson Industries, Inc.
Anesthesiology · 138d
Cleared Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · MKJ
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Dec 01, 1999
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135 · FZP
Applied Medical Resources
General & Plastic Surgery · 72d
Cleared Dec 01, 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203 · JHI
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Dec 01, 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317 · JHI
ACON Laboratories, Inc.
Chemistry · 58d
Cleared Dec 01, 1999
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56,...
K993388 · DHB
Pharmacia & Upjohn Co.
Immunology · 54d
Cleared Dec 01, 1999
APR METASUL ACETABULAR INSERT
K993569 · KWA
Sulzermedica
Orthopedic · 41d
Cleared Dec 01, 1999
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC...
K993577 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 41d
Cleared Dec 01, 1999
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
K993890 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 30, 1999
APEX LOCATOR BINGO-1020
K992233 · LQY
Dent Corp. Research & Development
Dental · 158d
Cleared Nov 30, 1999
CKHEMO, MODEL CKHEMO VERSION 1.0
K992255 · FKP
Csam, Inc.
Gastroenterology & Urology · 147d