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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83761–83784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310 · JJY
Dade Behring, Inc.
Chemistry · 57d
Cleared Nov 30, 1999
K-ASSAY IGM
K993323 · CFF
Kamiya Biomedical Co.
Immunology · 57d
Cleared Nov 30, 1999
RETIC-QUINOX
K993496 · JPK
Hematronix, Inc.
Hematology · 46d
Cleared Nov 30, 1999
K-ASSAY TRANSFERRIN
K993537 · DDG
Kamiya Biomedical Co.
Immunology · 42d
Cleared Nov 30, 1999
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
K993546 · JJY
Medical Analysis Systems, Inc.
Immunology · 42d
Cleared Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
K993642 · JJX
Roche Diagnostics Corp.
Immunology · 33d
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825 · JCN
Streck Laboratories, Inc.
Hematology · 18d
Cleared Nov 29, 1999
HYBRID CAPTURE II GC-ID
K981485 · LSL
Digene Corp.
Microbiology · 584d
Cleared Nov 29, 1999
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992862 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 96d