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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117937–117960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1992
XENON CIRCUIT
K914747 · IYT
Gibeck, Inc.
Radiology · 128d
Cleared Feb 27, 1992
APEX HELIX - A
K914807 · KPS
Elscint, Inc.
Radiology · 125d
Cleared Feb 27, 1992
SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)
K914954 · HQZ
Jsu Corp.
Ophthalmic · 114d
Cleared Feb 27, 1992
STERILETX POWDER FREE LATEX EXAMINATION GLOVES
K915189 · LYY
Transcorp
General Hospital · 101d
Cleared Feb 27, 1992
IR-192 IMPLANT, MODIFICATION
K915253 · IWA
Omnitron Intl., Inc.
Radiology · 101d
Cleared Feb 27, 1992
GUIDEWIRE INTRODUCER SET
K915421 · DYB
B. Braun of America, Inc.
Cardiovascular · 87d
Cleared Feb 27, 1992
IN THE EAR HEARING AID
K915450 · ESD
Zenith/Omni Hearing Instruments, Inc.
Ear, Nose, Throat · 84d
Cleared Feb 27, 1992
DESERET GUIDEWIRE INTRODUCER
K915496 · DQX
Bd Becton Dickinson Vacutainer...
Cardiovascular · 80d
Cleared Feb 27, 1992
FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
K915535 · KGI
Lunar
Radiology · 80d
Cleared Feb 27, 1992
INSTRUMENTARIUM MEGA4
K915552 · LNH
Instrumentarium Imaging, Inc.
Radiology · 78d
Cleared Feb 27, 1992
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
K915644 · KPS
Nuccardiac Software, Inc.
Radiology · 72d
Cleared Feb 27, 1992
ACID PHOSPHATASE REAGENT SET
K915705 · CKE
Tech Intl. Co.
Chemistry · 90d
Cleared Feb 27, 1992
S.A.A. EYE GLASS FRAMES
K915783 · HQZ
Yau Yee Optical Co., Ltd.
Ophthalmic · 65d
Cleared Feb 27, 1992
CANNABINOID EIA TEST
K920311 · LDJ
Diagnostic Reagents, Inc.
Toxicology · 35d
Cleared Feb 27, 1992
IL TEST CANNABINOID, 35282
K920418 · LDJ
Instrumentation Laboratory CO
Toxicology · 27d
Cleared Feb 27, 1992
EXTEND-EAR
K920466 · ESD
Sonovation, Inc. Dba Avr Sonovation
Ear, Nose, Throat · 31d
Cleared Feb 27, 1992
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
K920507 · DKZ
Syva Co.
Toxicology · 22d
Cleared Feb 27, 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · BTM
Puritan Bennett Corp.
Anesthesiology · 20d
Cleared Feb 26, 1992
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · GWF
Nihon Kohden America, Inc.
Neurology · 254d
Cleared Feb 26, 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · DQA
Sensor Medics Corp.
Anesthesiology · 187d
Cleared Feb 26, 1992
CATHWRITER(TM)
K914105 · DQK
Softheart, Inc.
Cardiovascular · 166d
Cleared Feb 26, 1992
PIKOS 01 & PIKOS E 01
K914109 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 166d
Cleared Feb 26, 1992
AIRWAY THERMISTOR
K914219 · BZG
Synectics-Dantec
Anesthesiology · 160d
Cleared Feb 26, 1992
THAYER EXPANSION CHAMBER METERED DOSE INHALER
K914283 · CAF
Thayer Medical Corp.
Anesthesiology · 155d