FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80929–80952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2000
GALAXY
K003007 · EJT
Sterngold
Dental · 52d
Cleared Nov 17, 2000
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE,...
K003132 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 42d
Cleared Nov 17, 2000
RESUSCITAIRE RADIANT WARMER
K003335 · FMT
Hill-Rom Air-Shields
General Hospital · 23d
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408 · JAK
GE Medical Systems
Radiology · 15d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529 · DPW
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Nov 16, 2000
SILENT NIGHT V
K000253 · MNR
Sleep Solutions, Inc.
Anesthesiology · 294d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · DXT
Medrad, Inc.
Cardiovascular · 169d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Dade Behring, Inc.
Hematology · 129d
Cleared Nov 16, 2000
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447 · DKZ
American Bio Medica Corp.
Toxicology · 99d
Cleared Nov 16, 2000
MULITPLE MALE LATX CONDOM
K002571 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Nov 16, 2000
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002,...
K002572 · GWG
Medtronic PS Medical
Neurology · 90d
Cleared Nov 16, 2000
ADVANCED UROSCIENCE INNERSHEATH
K002573 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · KPS
Cti Pet Systems, Inc.
Radiology · 87d
Cleared Nov 16, 2000
INVAC
K002608 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 87d
Cleared Nov 16, 2000
NEWGEN SYSTEM
K002619 · JEY
Stryker Instruments
Dental · 85d
Cleared Nov 16, 2000
SURESMILE SYSTEM
K002620 · EIA
Orametrix, Inc.
Dental · 85d
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774 · MOS
Mri Devices Corp.
Radiology · 71d
Cleared Nov 16, 2000
SSW-STERILE SOLUTION WARMER
K002859 · LHC
Kmi Kolster Methods, Inc.
General Hospital · 64d
Cleared Nov 16, 2000
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · DZL
Synthes (Usa)
Dental · 56d
Cleared Nov 16, 2000
HERACERAM
K002993 · EIH
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · JFY
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Nov 16, 2000
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K003399 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2000
ALLEGRO TB, ALLEGRO N
K003434 · KPS
Adac Laboratories
Radiology · 10d
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 167d