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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93457–93480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1997
MODEL 405T WITH ETCO2 OPTION
K964961 · CCK
Ivy Biomedical Systems, Inc.
Anesthesiology · 154d
Cleared May 14, 1997
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
K965052 · LPL
Wesley Jessen Corp.
Ophthalmic · 147d
Cleared May 14, 1997
CALTAG CAL-LYSE
K965232 · GKZ
Caltag Laboratories, Inc.
Hematology · 134d
Cleared May 14, 1997
REST X SYSTEM
K970428 · FNM
Restxsys
General Hospital · 99d
Cleared May 14, 1997
MYERSON'S ECONOMY DENTURE BASE MATERIAL
K970522 · EBI
Austenal, Inc.
Dental · 92d
Cleared May 14, 1997
TENOSNARE
K970562 · HRX
Luxtec Corp.
Orthopedic · 90d
Cleared May 14, 1997
MODEL 1700, HYDRO PREP
K970694 · GYB
Physiometrix, Inc.
Neurology · 78d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
K970784 · DXG
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · DPS
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799 · LIF
Alexander Mfg. Co.
Gastroenterology & Urology · 71d
Cleared May 14, 1997
SCANRITE DFS
K970850 · EHD
Scanrite Systems
Radiology · 68d
Cleared May 14, 1997
CEDIA DIGOXIN
K970881 · KXT
Boehringer Mannheim Corp.
Toxicology · 65d
Cleared May 14, 1997
B-350 CEILING MOUNTED C-POSITIONER
K970947 · JAA
Omega Medical Imaging, Inc.
Radiology · 61d
Cleared May 14, 1997
EPISTAXIS NASAL PACK
K971000 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 56d
Cleared May 14, 1997
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109 · DKZ
Drial Consultants, Inc.
Toxicology · 49d
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365 · IZI
Philips Medical Systems North...
Radiology · 30d
Cleared May 14, 1997
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
K971452 · IZZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared May 13, 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 210d
Cleared May 13, 1997
CHASE LEFT VENT SAFETY VALVE
K964391 · DWF
Chase Medical, Inc.
Cardiovascular · 190d
Cleared May 13, 1997
MBI ILLUMINATED RETINAL PICK
K964405 · MPA
M.B. Industries, Inc.
Ophthalmic · 190d
Cleared May 13, 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · MPA
M.B. Industries, Inc.
Ophthalmic · 181d
Cleared May 13, 1997
NUVO-LASE 660 LASER SYSTEM
K970667 · GEX
American Laser Medical
General & Plastic Surgery · 78d
Cleared May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · HQY
Yeong Jiuh Corp.
Ophthalmic · 77d
Cleared May 13, 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724 · DKZ
Drial Consultants, Inc.
Toxicology · 75d