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
106489–106512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1994
OLYMPIC BILI-LITE
K940996 · LBI
Olympic Medical Corp.
General Hospital · 196d
Cleared Sep 16, 1994
INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER
K941273 · HRX
Innovasive Devices, Inc.
Orthopedic · 184d
Cleared Sep 16, 1994
MT-300 CASSETTE HOLDER
K941600 · IXA
Medtec, Inc.
Radiology · 168d
Cleared Sep 16, 1994
INTERACOUSTICS CLINICAL AUDIOMETER
K941920 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 149d
Cleared Sep 16, 1994
MODEL #310T03500 WRIST COIL
K942355 · LNH
Medic, Inc.
Radiology · 122d
Cleared Sep 16, 1994
CEQUAL-QUANTITATIVE ANALYSIS
K942363 · KPS
Nuccardiac Software, Inc.
Radiology · 122d
Cleared Sep 16, 1994
KARL STORZ LASER ACCESSORIES
K942786 · GEX
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 94d
Cleared Sep 16, 1994
VISIONLINK DICOM MODULE
K942860 · KPS
Evergreen Technologies, Inc.
Radiology · 91d
Cleared Sep 16, 1994
STABILET
K942904 · FMT
Hill-Rom, Inc.
General Hospital · 87d
Cleared Sep 16, 1994
ALL-IN-THE-EAR
K943318 · ESD
Golden State Audiology Assoc.
Ear, Nose, Throat · 67d
Cleared Sep 16, 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · DQX
Cordis Corp.
Cardiovascular · 66d
Cleared Sep 16, 1994
THE ELITE SPECTRUM
K943396 · KCW
Instantron
General & Plastic Surgery · 64d
Cleared Sep 16, 1994
THE BLENDTONE ROYALE
K943398 · KCW
Instantron
General & Plastic Surgery · 64d
Cleared Sep 16, 1994
THE SS-99
K943399 · KCW
Instantron
General & Plastic Surgery · 64d
Cleared Sep 16, 1994
EPISTAT-II NASAL CATHETER
K943718 · EMX
Merocel Corp.
Ear, Nose, Throat · 46d
Cleared Sep 16, 1994
PROSHIELD PLUS MULTIPLE GLOVES
K943735 · LYY
Sino (U.S.A.) Co.
General Hospital · 45d
Cleared Sep 16, 1994
SOPHOS DENTAL DIAMOND
K943841 · DZP
Sophos Technologic
Dental · 42d
Cleared Sep 16, 1994
COLLAR BUTTON VENTURI VENT TUBE
K943848 · ETD
Micromed Development Corp.
Ear, Nose, Throat · 43d
Cleared Sep 16, 1994
END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM
K943927 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 35d
Cleared Sep 16, 1994
MICRO X-50 HF
K944147 · IZO
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-30HF
K944148 · IZO
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-80 HF
K944149 · IZO
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-65 HF
K944150 · IZO
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 15, 1994
PROPORTIONAL SOLENOID VALVE
K922102 · CBK
Puritan Bennett Corp.
Anesthesiology · 862d