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
149809–149832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1985
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · JHJ
Fisher Diagnostics
Chemistry · 75d
Cleared Jan 23, 1985
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
K844415 · MBF
Depuy, Inc.
Orthopedic · 70d
Cleared Jan 23, 1985
HIGH RESOLUTION 5 MHZ LINEAR ARRAY
K844449 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Jan 23, 1985
CIVCO SCAN DRAPE
K844472 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 65d
Cleared Jan 23, 1985
STORZ CORNEO-SCAN II CS2000
K844477 · IYO
Storz Instrument Co.
Radiology · 65d
Cleared Jan 23, 1985
ADVANCED HEARING INSTRUMENTS - HEARING AIDS
K844728 · ESD
Advanced Hearing Instruments
Ear, Nose, Throat · 50d
Cleared Jan 23, 1985
CARDIO IV/GXT STRESS TESTING SYSTEM
K844744 · DPS
Intl. Medical, Inc.
Cardiovascular · 49d
Cleared Jan 23, 1985
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
K844836 · GWD
Edward Weck, Inc.
Microbiology · 42d
Cleared Jan 23, 1985
VISISTAT SKIN STAPLING DEVICE
K844837 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 42d
Cleared Jan 23, 1985
SKIN STAT II SKIN STAPLING MEDICAL DEVICE
K844838 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 42d
Cleared Jan 23, 1985
IN THE EAR MODEL X-ITE 84
K844985 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1985
SYVA ADVANCE EMIT PHENYTOIN ASSAY
K844990 · LES
Syva Co.
Toxicology · 28d
Cleared Jan 23, 1985
EMIT PHENYTOIN ASSAY
K844991 · DIP
Syva Co.
Toxicology · 28d
Cleared Jan 23, 1985
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE
K850014 · EBH
Medi-Dent American, Inc.
Dental · 21d
Cleared Jan 23, 1985
TOWEL PACK, SURGICAL
K850016
East Texas Lighthouse For the Blind
General & Plastic Surgery · 21d
Cleared Jan 22, 1985
MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER
K844132 · LMB
Sigma Teleproducts, Inc.
Radiology · 91d
Cleared Jan 22, 1985
INFUSART
K844227 · FLN
Sartorius, Inc.
General Hospital · 82d
Cleared Jan 22, 1985
IV RATEMETER
K844309 · FLN
Aci Medical, Inc.
General Hospital · 77d
Cleared Jan 22, 1985
INFUSET W/HUBER NEEDLE
K844313 · FMI
Med Fusion Systems, Inc.
General Hospital · 77d
Cleared Jan 22, 1985
TITERTEK MICROPLATE WASHER 120
K844500 · JTC
Flow Laboratories, Inc.
Microbiology · 63d
Cleared Jan 22, 1985
DR-2C
K844650 · DXJ
General Devices
Cardiovascular · 54d
Cleared Jan 22, 1985
TITMUS VISION TESTER II
K844694 · HIT
Titmus Optical, Inc.
Ophthalmic · 50d
Cleared Jan 22, 1985
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 56d
Cleared Jan 22, 1985
NEPHROSS ALLEGRO H.F.
K844748 · FKQ
Organon Teknika Corp.
Gastroenterology & Urology · 47d