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
156217–156240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1983
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · CIG
Gilford Diagnostics
Chemistry · 40d
Cleared Jul 18, 1983
DIRECT BILIRUBIN REAGENT
K831844 · CIG
Gilford Diagnostics
Chemistry · 40d
Cleared Jul 18, 1983
CALIBRATOR 282
K831872 · KRZ
Bionostics, Inc.
Hematology · 35d
Cleared Jul 18, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
K831902 · DDZ
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBITT ANTISERUM TO HUMAN C3C
K831905 · CZW
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGG
K831908 · DGK
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909 · CZN
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
ANTINUCLEAR ANTIBODY TEST KIT
K831927 · DAA
Breit Laboratories, Inc.
Immunology · 33d
Cleared Jul 18, 1983
LEAP RHEUMATOID FACTOR TEST KIT
K831941 · DHR
Cooper Diagnostics, Inc.
Immunology · 32d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956 · CZJ
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · DAD
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Jul 18, 1983
VIVONEX TUNGSTEN TIP TUBE-MONOFILA-
K831970 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 1983
STOMACH TUBE LEVIN TUBE
K831974 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 1983
MODEL #27224P CONTINUOUS FLOW PUMP
K832009 · OCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 18, 1983
CERTAIN HB CO-OXIMETER CONTROL
K832028 · JJS
Corning Medical & Scientific
Hematology · 25d
Cleared Jul 18, 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036 · CEM
Bd Becton Dickinson Vacutainer...
Chemistry · 24d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038 · GKL
Abbott Diagnostics
Hematology · 24d
Cleared Jul 18, 1983
EXTERNAL INCONTINENCE CATHETER SET-NON
K832108 · KNX
Plasco, Inc.
Gastroenterology & Urology · 19d
Cleared Jul 18, 1983
EXTERNAL INCONTINENCE CATHETER TAKE-HOME
K832109 · KNX
Plasco, Inc.
Gastroenterology & Urology · 19d
Cleared Jul 18, 1983
DACOMED SNAP-GAUGE
K832121 · LIL
Dacomed Corp.
Gastroenterology & Urology · 18d
Cleared Jul 14, 1983
GENERAL SURGICAL INSTRUMENTS
K831805 · GEN
Aim Corp.
General & Plastic Surgery · 38d
Cleared Jul 12, 1983
SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
K822411 · EIB
Western Advanced Technology, Inc.
Dental · 336d
Cleared Jul 12, 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 315d
Cleared Jul 12, 1983
PORTABLE MONITORING & SCREENING SPIROM.
K822689 · BZK
Boehringer Laboratories
Anesthesiology · 312d