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
125185–125208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1990
TOY SUNGLASSES
K901802 · HQY
Sirco Intl. Corp.
Ophthalmic · 90d
Cleared Jul 19, 1990
FLEXIBLE EXTENDER
K902035 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 77d
Cleared Jul 19, 1990
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · FLF
3M Company
General Hospital · 77d
Cleared Jul 19, 1990
BLOOD GAS/ISE CONTROLS
K902094 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 72d
Cleared Jul 19, 1990
TRACHEAL TUBE STYLET
K902180 · BSR
Sims Surgical, Inc.
Anesthesiology · 65d
Cleared Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · JXG
Codman & Shurtleff, Inc.
Neurology · 59d
Cleared Jul 19, 1990
ANGIOGRAPHY DRAPE PACK
K902293 · LRO
Biocor Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 19, 1990
EASY BREATHER MODEL 100 ACCESSORIES
K902300 · BYT
Progressive Productions , Ltd.
Anesthesiology · 57d
Cleared Jul 19, 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
K902344 · FRC
Ati
General Hospital · 55d
Cleared Jul 19, 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 49d
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