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
168889–168912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1979
DEXIDE DISPOSABLE SWAB STICK
K791169 · KXF
Dexide, Inc.
General Hospital · 35d
Cleared Jul 30, 1979
SURFLO INJECTION PLUG
K791173 · FPA
Terumo America, Inc.
General Hospital · 35d
Cleared Jul 30, 1979
3M COLD/HOT WATER BAG AND WRAP
K791176 · FPF
3M Company
General Hospital · 35d
Cleared Jul 30, 1979
ACMI RIGI-FLEX NEPHORSCOPE
K791182 · FGA
American Cystocope Makers, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 30, 1979
DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN
K791195 · JAK
Ohio Nuclear, Inc.
Radiology · 34d
Cleared Jul 30, 1979
URIDROP
K791196 · KNX
Ab Medett Produkter
Gastroenterology & Urology · 34d
Cleared Jul 30, 1979
URIDROP SPECIAL
K791197 · KNK
Ab Medett Produkter
Chemistry · 34d
Cleared Jul 30, 1979
BIBAG
K791198 · KNX
Ab Medett Produkter
Gastroenterology & Urology · 34d
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 31d
Cleared Jul 30, 1979
TRIDOROS 712
K791214 · IZO
Siemens Corp.
Radiology · 28d
Cleared Jul 30, 1979
INHALATION OPERATED NEBULIZER CODE
K791218 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 28d
Cleared Jul 30, 1979
UNILITH PULSE GENERATOR
K791219 · DXY
Ela Medical, Inc.
Cardiovascular · 27d
Cleared Jul 30, 1979
CYBER DX 100
K791229 · BZM
Cyber Diagnostics
Anesthesiology · 21d
Cleared Jul 30, 1979
CONPHAR SUCTION CATHETER-W/0 CONTROL
K791253 · BSY
Conphar, Inc.
Anesthesiology · 24d
Cleared Jul 30, 1979
FELTLOC CAST PADDING
K791305 · ITG
Howmedica Corp.
Physical Medicine · 14d
Cleared Jul 30, 1979
UCG-LYPHOTEST
K791309 · JHJ
Wampole Laboratories
Chemistry · 14d
Cleared Jul 30, 1979
VERTEBRACE SPINAL SUPPORTS
K791314 · IPY
Vertebrace, Inc.
Physical Medicine · 14d
Cleared Jul 30, 1979
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · KHO
Bio-Rad
Chemistry · 12d
Cleared Jul 24, 1979
PULSE GENERATOR, MODEL 171
K782161 · DXY
Telectronics, Inc.
Cardiovascular · 215d
Cleared Jul 24, 1979
BATTERY CHARGER, 171 PACEMAKER
K782162 · DXY
Telectronics, Inc.
Radiology · 215d
Cleared Jul 24, 1979
RIA, INSULIN, DOUBLE ANTIBODY
K790630 · CFP
Endocrine-Metabolic Center
Chemistry · 119d
Cleared Jul 24, 1979
CORNING PARAPROTEIN SCREENING
K790667 · CFF
Corning Medical & Scientific
Immunology · 109d
Cleared Jul 24, 1979
MODEL 4000, SPECTROPHOTOMETER
K790795 · JXR
The Perkin-Elmer Corp.
Toxicology · 91d
Cleared Jul 24, 1979
DUALUME LARYNGEAL EXAMINATION TELESCOPE
K790845 · ENZ
National Medical Technology
Ear, Nose, Throat · 81d