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
168505–168528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1979
ADAC TOMOGRAPHY OPTION
K791055 · KPS
Adac Laboratories
Radiology · 102d
Cleared Sep 17, 1979
STIMULATOR MODEL SSS-1101
K791149 · GWE
Nihon Kohden America, Inc.
Neurology · 94d
Cleared Sep 17, 1979
MYVACET 5-07, 7-00 AND 9-40
K791178 · IXI
Radiation Products Design, Inc.
Radiology · 84d
Cleared Sep 17, 1979
SCINTISTRESS SYSTEM
K791201 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 81d
Cleared Sep 17, 1979
KOLPOSKOP KP20005
K791279 · HEX
Elmed, Inc.
Obstetrics & Gynecology · 69d
Cleared Sep 17, 1979
DORN BLOOD CULTURE COLLECTION TUBE
K791303 · JKA
Wadley Institutes of Molecular Medici
Chemistry · 63d
Cleared Sep 17, 1979
IREX REAL TIME PHASED ARRAY SYSTEM
K791317 · CDP
Irex Corp.
Radiology · 67d
Cleared Sep 17, 1979
MODEL 1338A CRT DISPLAY
K791343 · IYO
Hewlett-Packard Co.
Radiology · 68d
Cleared Sep 17, 1979
MODEL 1350 GRAPHICS TRANSLATOR
K791344 · IYO
Hewlett-Packard Co.
Radiology · 68d
Cleared Sep 17, 1979
ROUND WASHBASIN & RECTANGLE WASHBASIN
K791348
General Clinical Plastics Corp.
General Hospital · 67d
Cleared Sep 17, 1979
CODE QAS 103 ANTI-DNA CONTROLS
K791354 · KTL
Amersham Corp.
Immunology · 61d
Cleared Sep 17, 1979
EARETTE HEARING AID
K791356 · ESD
Oticon Corp.
Ear, Nose, Throat · 59d
Cleared Sep 17, 1979
VENTRE/SEP T4 TEST SET
K791368 · CDX
Ventrex Laboratories, Inc.
Chemistry · 54d
Cleared Sep 17, 1979
MODEL F-1010 DIGITAL THERMOMETER
K791371 · FLL
Filac Corp.
General Hospital · 55d
Cleared Sep 17, 1979
125I LEUTINIZING HORMONE RIA KIT
K791405 · CEP
Diagnostic Products Corp.
Chemistry · 48d
Cleared Sep 17, 1979
MODIFIED THAYER-MARTIN AGAR (PLATE)
K791425 · JTY
American Laboratory Supply, Inc.
Microbiology · 53d
Cleared Sep 17, 1979
KOTEX LIGHTDAYS DEODORANT PATILINERS
K791433 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 52d
Cleared Sep 17, 1979
MARTIN LEWIS JEMBEC CSI 8872
K791446 · JTY
Clinical Sciences, Inc.
Microbiology · 48d
Cleared Sep 17, 1979
MARTIN LEWIS AGAR CSI 3169
K791447 · JTY
Clinical Sciences, Inc.
Microbiology · 48d
Cleared Sep 17, 1979
PARA-VENT
K791463 · BTC
Cameron Medical Corp.
Anesthesiology · 42d
Cleared Sep 17, 1979
MOSQUITO ARTERIAL BLOOD SAMPLER
K791465 · CBT
Emde Corp.
Anesthesiology · 48d
Cleared Sep 17, 1979
ROHNAR 7000 DIGITAL DIAGN ULTRASOUND
K791505 · IYO
Roche Scientific Corp.
Radiology · 45d
Cleared Sep 17, 1979
THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR
K791542 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 38d
Cleared Sep 17, 1979
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
K791543 · JSM
Isle Media and Sterile Products, Inc.
Microbiology · 38d