FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
119329–119352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1992
LATEX PATIENT EXAMINATION GLOVES - HYPOALLERGENIC
K914709 · LYY
Klh Medical, Inc.
General Hospital · 84d
Cleared Jan 10, 1992
PROPAQ 102,104,106,102EL,104EL,&106EL
K914838 · MHX
Protocol Systems, Inc.
Cardiovascular · 77d
Cleared Jan 10, 1992
OPTI-AMP
K914876 · GWL
Intelligent Hearing Systems
Neurology · 73d
Cleared Jan 10, 1992
SONOTONE BEHIND THE EAR MODEL ST 54-0
K914897 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 71d
Cleared Jan 10, 1992
OXYGUARD
K914978 · MNK
Stantex Pty , Ltd.
Gastroenterology & Urology · 65d
Cleared Jan 10, 1992
AMCATH DISPOSABLE BIOPSY FORCEPS
K915142 · FCF
Intl. Medical, Inc.
Gastroenterology & Urology · 57d
Cleared Jan 09, 1992
HEMOCLIP II
K911915 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 254d
Cleared Jan 09, 1992
CONVERTRAY, MODIFICATION
K912001 · ELW
Wilde Dental (Usa)
Dental · 267d
Cleared Jan 09, 1992
ABCOM 2000
K912562 · DPW
Applied Biometrics, Inc.
Radiology · 212d
Cleared Jan 09, 1992
CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
K912776 · ITX
Cardio Metrics, Inc.
Radiology · 199d
Cleared Jan 09, 1992
SC1150 CW/PD
K912819 · IYN
Pie Medical Equipment B.V.
Radiology · 198d
Cleared Jan 09, 1992
MODEL SONICAID AXIS
K912890 · HGM
Oxford Medilog, Inc.
Obstetrics & Gynecology · 192d
Cleared Jan 09, 1992
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077 · DTR
Dlp, Inc.
Cardiovascular · 182d
Cleared Jan 09, 1992
PRESSURE INFUSER
K913751 · KZD
Biomedical Dynamics, Inc.
General Hospital · 141d
Cleared Jan 09, 1992
STAR SYNC, MODIFICATION
K913972 · CBK
Infrasonics Corp.
Anesthesiology · 126d
Cleared Jan 09, 1992
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
K914026 · FPA
E-Z-Em, Inc.
General Hospital · 121d
Cleared Jan 09, 1992
LM- LAP 10 HIGH FLOW INSUFFLATOR
K914201 · HIF
Leisegang Medical, Inc.
Obstetrics & Gynecology · 112d
Cleared Jan 09, 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
K914255 · JJY
Bio-Rad
Chemistry · 108d
Cleared Jan 09, 1992
ECHOSIGHT STENT SET
K914280 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 107d
Cleared Jan 09, 1992
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
K914608 · GAA
Dlp, Inc.
General & Plastic Surgery · 84d
Cleared Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
K914811 · LBR
Instrumentation Laboratory CO
Chemistry · 76d
Cleared Jan 09, 1992
K-CAP-E, STERILE
K914812 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 76d
Cleared Jan 09, 1992
DSL INSULIN RIA (DSL 1600)
K914820 · CFP
Diagnostic Systems Laboratories, Inc.
Chemistry · 76d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 47I
K914898 · ESD
Sonotone Hearing Instruments
Ear, Nose, Throat · 70d