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
150817–150840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1984
MEA110
K843822 · GZJ
Canadian Medical Products
Neurology · 24d
Cleared Oct 22, 1984
HEATED RESPIRATORY HUMIDIFIER MR428
K843903 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 19d
Cleared Oct 19, 1984
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · DXK
Interspec, Inc.
Cardiovascular · 207d
Cleared Oct 19, 1984
CARDIO METRIC CUSTOM PERFUSION TUBING
K841959 · DWE
Sterile Design, Inc.
Cardiovascular · 158d
Cleared Oct 19, 1984
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 148d
Cleared Oct 19, 1984
VF-PD-120
K842460 · JOP
Valpey-Fisher Corp.
Cardiovascular · 119d
Cleared Oct 19, 1984
WET-STOP
K842547 · KPN
Palco Laboratories, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 19, 1984
RADIONUCLIDE INFUSION SYSTEM
K842568 · FRN
Squibb Diagnostics
General Hospital · 109d
Cleared Oct 19, 1984
UROPUMP MODEL 1711
K843224 · FFG
Life-Tech Intl., Inc.
Gastroenterology & Urology · 64d
Cleared Oct 19, 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · FRN
American Edwards Laboratories
General Hospital · 60d
Cleared Oct 19, 1984
LS-260G MONITOR/RECORDER & DEFIBILLATOR
K843396 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 51d
Cleared Oct 19, 1984
MOLINEA PANTY
K843403 · EYQ
Paul Hartmann Corp.
Gastroenterology & Urology · 50d
Cleared Oct 19, 1984
MOLINEA INCONTINENT PAD
K843404 · EYQ
Paul Hartmann Corp.
Gastroenterology & Urology · 50d
Cleared Oct 19, 1984
MOLICARE
K843405 · EYQ
Paul Hartmann Corp.
Gastroenterology & Urology · 50d
Cleared Oct 19, 1984
INTERCEPT
K843591 · KDP
Vital Signs, Inc.
General Hospital · 37d
Cleared Oct 19, 1984
MINISET VEIN INFUSION SETS
K843631 · FPA
Travenol Laboratories, S.A.
General Hospital · 32d
Cleared Oct 19, 1984
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K843714 · BTR
Ohmeda Medical
Anesthesiology · 25d
Cleared Oct 19, 1984
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · BTO
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 19, 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · BTO
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 19, 1984
THERMAL GRAYSCALE RF-100
K843836 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 18d
Cleared Oct 18, 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · DSI
Hewlett-Packard Co.
Cardiovascular · 196d
Cleared Oct 18, 1984
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
K841585 · KDI
American Bentley
Gastroenterology & Urology · 184d
Cleared Oct 18, 1984
ELECTRODE CATHETER, ORTHOGONAL TYPE
K841802 · LDF
Webster Laboratories, Inc.
Cardiovascular · 170d
Cleared Oct 18, 1984
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481 · LYK
American Edwards Laboratories
Cardiovascular · 115d