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
92953–92976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 25, 1997
CONTIDRAIN CATHETER
K964757 · EZL
Contimed, Inc.
Gastroenterology & Urology · 210d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 198d
Cleared Jun 25, 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · MNH
Aesculap, Inc.
Orthopedic · 152d
Cleared Jun 25, 1997
CARDIOVIT CS-200
K970879 · LOS
Schiller America, Inc.
Cardiovascular · 107d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · MBI
Boston Scientific Corp
Orthopedic · 89d
Cleared Jun 25, 1997
MULTITAK SS SUTURE SYSTEM
K971144 · MBI
Bonutti Research
Orthopedic · 89d
Cleared Jun 25, 1997
SPLITSCREEN (ME-975)
K971153 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
MULTIPICS(ME-977)
K971154 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
SATELLITE
K971331 · GWQ
Nicolet Biomedical, Inc.
Neurology · 76d