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

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175,820 results
125785–125808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · DIS
Syva Co.
Toxicology · 38d
Cleared Jul 19, 1990
EPC ELECTRONIC PIPETTING SYSTEM
K902592 · JQW
Ulster Scientific, Inc.
Chemistry · 37d
Cleared Jul 19, 1990
BILIRUBIN CONTROL
K902616 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 36d
Cleared Jul 19, 1990
BILATERAL TMJ COIL
K902630 · LNH
Resonex, Inc.
Radiology · 35d
Cleared Jul 19, 1990
MODELS 4201, 4231 & 4235 EXTENSION CABLES
K902679 · DTE
Pace Medical
Cardiovascular · 30d
Cleared Jul 19, 1990
AFFINITY PROLACTIN TEST SYSTEM
K902698 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Jul 19, 1990
SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT
K902719 · GXY
Labeltape Meditect, Inc.
Neurology · 29d
Cleared Jul 19, 1990
ASPEN 3 OXYGEN CONCENTRATOR
K902890 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 17d
Cleared Jul 18, 1990
CWD/PPG MODULE
K896500 · JOM
Life Sciences Manufacturing, Inc.
Cardiovascular · 246d
Cleared Jul 18, 1990
PAG MICROPROCESSOR-CONTROLLED MODULE
K900365 · DQC
Life Sciences Manufacturing, Inc.
Cardiovascular · 174d
Cleared Jul 18, 1990
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE
K900451 · DRT
Pace Tech, Inc.
Cardiovascular · 169d
Cleared Jul 18, 1990
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
K900664 · DRC
Sterimed, Inc.
Cardiovascular · 155d
Cleared Jul 18, 1990
LOW FLOW N2O/02O MICROBLENDER
K900722 · BZR
Bird Products Corp.
Anesthesiology · 154d
Cleared Jul 18, 1990
MDI ADAPTOR
K900783 · CAF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 148d
Cleared Jul 18, 1990
IMPRAFLO AUTOTRANSFUSION DEVICE
K901232 · CAC
Impra, Inc.
Anesthesiology · 126d
Cleared Jul 18, 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · DRX
Medtronic Vascular
Cardiovascular · 106d
Cleared Jul 18, 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · DQA
Hewlett-Packard Co.
Anesthesiology · 86d
Cleared Jul 18, 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · DRX
3M Company
Cardiovascular · 71d
Cleared Jul 18, 1990
CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
K902114 · BSK
Diemolding Corp.
Anesthesiology · 68d
Cleared Jul 18, 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · LDD
Marquette Electronics, Inc.
Cardiovascular · 36d
Cleared Jul 18, 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · CAC
Cobe Laboratories, Inc.
Anesthesiology · 23d
Cleared Jul 18, 1990
ZEPPELIN INSTRUMENTS
K902850 · HAO
Ruggles Corp.
Neurology · 19d
Cleared Jul 17, 1990
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · BZQ
S & W Medico Teknik
Anesthesiology · 655d
Cleared Jul 17, 1990
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · LOS
Hewlett-Packard Co.
Cardiovascular · 308d