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
156985–157008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 71d
Cleared Apr 27, 1983
ELECTROSURGICAL CAULTERY PENCIL
K830532 · GEI
American V. Mueller
General & Plastic Surgery · 68d
Cleared Apr 27, 1983
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
K830588 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · KDI
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 27, 1983
GENT-L-SPEC DISPOS. VAGINAL SPECULUM
K830725 · HIB
Geneva Laboratories, Inc.
Obstetrics & Gynecology · 50d
Cleared Apr 27, 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817 · DGC
Ventrex Laboratories, Inc.
Immunology · 43d
Cleared Apr 27, 1983
MICRO-MITT
K830821 · FXP
CooperVision, Inc.
General Hospital · 43d
Cleared Apr 27, 1983
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
K830888 · EQN
National Medical Technology
Ear, Nose, Throat · 37d
Cleared Apr 27, 1983
SURGICAL FACE MASK
K830890 · FXX
Busse Hospital Disposables, Inc.
General Hospital · 37d
Cleared Apr 27, 1983
ACTH RIA SYSTEM-DSI 2300
K830893 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 37d
Cleared Apr 27, 1983
I.E.C COLUMN
K830918 · KEA
Berwick Medical Products, Inc.
Chemistry · 36d
Cleared Apr 27, 1983
NETILMICIN 30MCG. SENSITIVITY DISCS
K830956 · JTN
Difco Laboratories, Inc.
Immunology · 33d
Cleared Apr 27, 1983
I.V. CATHETER PLACEMENT UNIT POLYURETH
K830972 · FOZ
Critikon Company, LLC
General Hospital · 30d
Cleared Apr 27, 1983
GIREX
K831033 · ION
Lancer Assoc.
Physical Medicine · 27d
Cleared Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · LLL
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Apr 27, 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045 · DHB
Pharmacia, Inc.
Immunology · 27d
Cleared Apr 27, 1983
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
K831054 · DHN
Immuno-Products Industries
Immunology · 26d
Cleared Apr 27, 1983
NEW ALLERGEN DISC -VAST VENTEX ALLERGY
K831091 · DHB
Ventrex Laboratories, Inc.
Immunology · 23d
Cleared Apr 27, 1983
TIA-IGG REAGENT & CALIBRATOR SETS
K831101 · DEW
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 27, 1983
TIA-IGA REAGENT & CALIBRATOR SETS
K831102 · CZP
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 27, 1983
TIA-IGM REAGENT & CALIBRATOR SETS
K831103 · DFT
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 26, 1983
INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
K830121 · JWH
Zimmer, Inc.
Orthopedic · 105d
Cleared Apr 26, 1983
ELECTRODE 3799
K831046 · GXY
Medtronic Vascular
Neurology · 26d