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
86521–86544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
K990248 · IYO
Dicomit Imaging Systems Corp.
Radiology · 80d
Cleared Apr 16, 1999
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV...
K990281 · LPL
Nissel , Ltd.
Ophthalmic · 78d
Cleared Apr 16, 1999
KINGLI ACUPUNCTURE NEEDLE
K990406 · MQX
United Pacific Co., Ltd.
General Hospital · 66d
Cleared Apr 16, 1999
STRAUMANN EXTRAORAL IMPLANT SYSTEM
K990458 · KCZ
Straumann USA
General & Plastic Surgery · 63d
Cleared Apr 16, 1999
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K990715 · KPR
Shimadzu Corp.
Radiology · 43d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · JIT
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · DCN
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 16, 1999
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
K990928 · DIE
Bio-Rad
Toxicology · 28d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON...
K974236 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 519d
Cleared Apr 15, 1999
BLEASE 6200 ANAESTHESIA VENTILATOR
K982132 · CBK
Blease Medical Equipment , Ltd.
Anesthesiology · 302d
Cleared Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR...
K983341 · JAQ
Nucletron Corp.
Radiology · 204d
Cleared Apr 15, 1999
QUANTA LITE LYME IGG ELISA
K984222 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
QUANTA LITE LYME IGM ELISA
K984234 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 118d
Cleared Apr 15, 1999
ALTHIN MEDICAL AB ALTRACART II
K990010 · KPO
Althin Medical AB
Gastroenterology & Urology · 101d
Cleared Apr 15, 1999
OPART
K990260 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · DKZ
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
K990409 · DMY
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
VIEW COM
K990759 · LLZ
Electromed Intl., Ltd.
Radiology · 38d
Cleared Apr 15, 1999
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH...
K990919 · LLZ
Visualization Technology, Inc.
Radiology · 28d
Cleared Apr 15, 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3,...
K991076 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8,...
K991078 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d