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
93457–93480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778 · HWC
Osteonics Corp.
Orthopedic · 44d
Cleared Jun 26, 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE...
K963732 · JOH
Mallinckrodt Medical
Anesthesiology · 282d
Cleared Jun 26, 1997
THERATRON 780E
K964606 · IWB
Theratronics, Inc.
Radiology · 220d
Cleared Jun 26, 1997
BAIR HUGGER MODEL 630 CARDIAC BLANKET
K964673 · DWJ
Augustine Medical, Inc.
Cardiovascular · 217d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · GGN
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
STA-LIATEST D-DI TEST KIT
K964728 · DAP
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969 · MOS
GE Medical Systems
Radiology · 196d
Cleared Jun 26, 1997
ESCORT LINK CENTRAL STATION MONITOR
K970012 · DSI
Medical Data Electronics
Cardiovascular · 175d
Cleared Jun 26, 1997
CLINICATH IR PERIPHERALLY INSERTED CATHETER
K970269 · LJS
Sims Deltec, Inc.
General Hospital · 154d
Cleared Jun 26, 1997
QUIKSTRIP ONE STEP METHAMPHETAMINE
K970395 · DKZ
Drial Consultants, Inc.
Toxicology · 143d
Cleared Jun 26, 1997
BOBCAT DX
K970543 · IPL
Quest Enabling Designs , Ltd.
Physical Medicine · 134d
Cleared Jun 26, 1997
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
K971167 · IZD
Neoprobe Corp.
Radiology · 87d
Cleared Jun 26, 1997
IDS4 IMAGE DISPLAY SYSTEM SERIES
K971368 · LLZ
O Tech, Inc.
Radiology · 73d
Cleared Jun 26, 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451 · LMB
O Tech, Inc.
Radiology · 66d
Cleared Jun 26, 1997
SYNERMED IR 200 CHEMISTRY ANALYZER
K971491 · JJF
Synermed, Inc.
Chemistry · 63d
Cleared Jun 26, 1997
ENDO-SEAL
K971899 · KIF
Ultradent Products, Inc.
Dental · 35d
Cleared Jun 26, 1997
MEDIVISION SINOSCOPE
K971995 · EOB
Medivision Scope Service Center, Inc.
Ear, Nose, Throat · 27d
Cleared Jun 26, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
K972070 · JJY
Nichols Institute Diagnostics
Chemistry · 23d
Cleared Jun 26, 1997
EPI-MAX EPISTAXIS CATHETER
K972076 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Jun 26, 1997
EPI-STOP EPISTAXIS CATHETER
K972077 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Jun 26, 1997
TV MONITOR (P12/17)
K972136 · IZI
Perkins Mfg. Co.
Radiology · 20d
Cleared Jun 26, 1997
SPECTACLE FRAMES (NON-PRESCRIPTION)
K972246 · HQY
Alimar Trading, Inc.
Ophthalmic · 10d
Cleared Jun 25, 1997
MODEL ME 300 MUSCLE TESTER
K943535 · HCC
Regulatory Strategies, Inc.
Neurology · 1070d
Cleared Jun 25, 1997
HARMAC QUADPOLAR MAPPING PACING CATHETER
K963074 · DRF
Harmac Medical Products, Inc.
Cardiovascular · 362d