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
100081–100104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1995
COMFEEL:ALGINATE FILLER
K954857 · KMF
Coloplast Corp.
General & Plastic Surgery · 22d
Cleared Nov 14, 1995
MEROCEL SOFT WOUND DRESSING
K954919 · KMF
Merocel Corp.
General & Plastic Surgery · 19d
Cleared Nov 14, 1995
WELCH ALLYN BI-OTOSCOPE
K955043 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 11d
Cleared Nov 13, 1995
PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K940188 · CCC
Biomedical Sensors, Ltd.
Anesthesiology · 669d
Cleared Nov 13, 1995
ARCHIVEMANAGER
K950513 · LMD
Cemax, Inc.
Radiology · 280d
Cleared Nov 13, 1995
OB/GYN PACKS
K951081 · KNA
Sterile Concepts, Inc.
Obstetrics & Gynecology · 249d
Cleared Nov 13, 1995
OPERATING ARM SYSTEM (OAS)
K951262 · LLZ
Radionics Software Applications, Inc.
Radiology · 237d
Cleared Nov 13, 1995
ADVANTAGE SIM
K951830 · KPQ
General Electric Co.
Radiology · 207d
Cleared Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
K951943 · JBQ
Helena Laboratories
Hematology · 201d
Cleared Nov 13, 1995
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292 · BZD
Puritan Bennett Corp.
Anesthesiology · 181d
Cleared Nov 13, 1995
AXSYM METHADONE
K953499 · DJR
Abbott Laboratories
Toxicology · 110d
Cleared Nov 13, 1995
HEARING TODAY HEARING AID
K953603 · ESD
Hearing Today Laboratory, Inc.
Ear, Nose, Throat · 103d
Cleared Nov 13, 1995
SIEMENS MULTILEAF COLLIMATOR
K953894 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 13, 1995
SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER
K953909 · DQY
Scimed
Cardiovascular · 84d
Cleared Nov 13, 1995
QUINTEST
K953939 · SCL
Bayer Corp.
General Hospital · 90d
Cleared Nov 13, 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · GGP
American Bioproducts Co.
Hematology · 80d
Cleared Nov 13, 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · GGP
American Bioproducts Co.
Hematology · 77d
Cleared Nov 13, 1995
ASPECT DIGITAL FORMATTER
K954149 · LMC
Aspect Electronics, Inc.
Radiology · 69d
Cleared Nov 13, 1995
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 68d
Cleared Nov 13, 1995
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
K954336 · EOB
Aust & Taylor Medical Corp.
Ear, Nose, Throat · 56d
Cleared Nov 13, 1995
GENOTROPIN MIXER
K954337 · FMF
Pharmacia, Inc.
General Hospital · 56d
Cleared Nov 13, 1995
IMMULITE THEOPHYLLINE
K954569 · KLS
Diagnostic Products Corp.
Toxicology · 42d
Cleared Nov 13, 1995
OTICON
K954794 · ESD
Oticon, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 13, 1995
COAST HEARING CHS (CUSTOM HEARING SYSTEM)
K954937 · ESD
Coast Hearing Services
Ear, Nose, Throat · 189d