FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
108001–108024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · JXM
Microgenics Corp.
Toxicology · 54d
Cleared Aug 01, 1994
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K942812 · DXC
Bio-Vascular, Inc.
Cardiovascular · 48d
Cleared Aug 01, 1994
ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES
K942940 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 40d
Cleared Aug 01, 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K943151 · LYY
Shield Gloves Medical Products Sdn Bhd
General Hospital · 40d
Cleared Aug 01, 1994
ARGESOL 750PY
K943208 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
ARGESOL PNP
K943209 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
ARGESOL #1005Y
K943210 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
ARGESOL 750Y
K943211 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
ARGESOL #830Y
K943212 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
ARGIPLUS LO
K943213 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
SOLDER #204
K943214 · EJT
Argen Precious Metals, Inc.
Dental · 27d
Cleared Aug 01, 1994
SOLDER #205
K943264 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Aug 01, 1994
SOLDER #210
K943266 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Aug 01, 1994
SOLDER #211
K943267 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Aug 01, 1994
SOLDER #209
K943269 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Aug 01, 1994
SOLDER #206
K943271 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Aug 01, 1994
TRI HAWK BUR, FG BUR
K943273 · EJL
Tri Hawk Corp.
Dental · 25d
Cleared Jul 29, 1994
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
K923727 · KDI
Minntech Corp.
Gastroenterology & Urology · 732d
Cleared Jul 29, 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
K932508 · JAK
Elscint, Inc.
Radiology · 430d
Cleared Jul 29, 1994
THERATOUCH 4.7
K932868 · LIH
Rich-Mar Corp.
Neurology · 410d
Cleared Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
K934513 · FPA
Abbott Laboratories
General Hospital · 317d
Cleared Jul 29, 1994
NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST
K935435 · IYE
Victoreen, Inc.
Radiology · 261d
Cleared Jul 29, 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
K935875 · LPH
Osteonics Corp.
Orthopedic · 232d
Cleared Jul 29, 1994
RIT 113 FILM ANALYSIS SYSTEM
K935928 · IYE
Radiological Imaging Technology, Inc.
Radiology · 228d