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
73081–73104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2003
LFRE INDIRECT LARYNGOSCOPE
K023004 · EOB
Astralite Corp.
Ear, Nose, Throat · 141d
Cleared Jan 28, 2003
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070 · ERL
Sodemsystems
Ear, Nose, Throat · 134d
Cleared Jan 28, 2003
GAS SAMPLING LINES
K023579 · CCK
Promedic, Inc.
Anesthesiology · 96d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · JJE
Beckman Coulter, Inc.
Chemistry · 77d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 28, 2003
PRECIMED HIP SCREW SYSTEM
K023851 · KTT
Precimed, Inc.
Orthopedic · 70d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901 · LZO
Howmedica Osteonics Corp.
Orthopedic · 67d
Cleared Jan 28, 2003
TRILUMINA THERAPEUTIC LASER SYSTEM
K023935 · NHN
Texas Applied Biomedical Services
Physical Medicine · 63d
Cleared Jan 28, 2003
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024081 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 48d
Cleared Jan 28, 2003
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
K024174 · LYZ
General Gloves Corp.
General Hospital · 41d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Jan 28, 2003
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
K024373 · LGZ
Elltec Co., Ltd.
General Hospital · 28d
Cleared Jan 28, 2003
SOFT TISSUE ANCHORING WASHERS
K030031 · KGS
Accu-Speed, Incorporated
General & Plastic Surgery · 25d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083 · LJT
Boston Scientific Corp
General Hospital · 19d
Cleared Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K030150 · JJY
Cliniqa Corporation
Chemistry · 13d
Cleared Jan 27, 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892 · DXT
Acist Medical Systems
Cardiovascular · 314d
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750 · MML
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jan 27, 2003
TERABYTE 2000 HAIR REMOVER
K022341 · GEX
Terabyte Co.
General & Plastic Surgery · 193d
Cleared Jan 27, 2003
ERA 3000
K022360 · DTA
Biotronik, Inc.
Cardiovascular · 192d
Cleared Jan 27, 2003
CELSIUS CONTROL SYSTEM
K022366 · NCX
Innercool Therapies
Neurology · 189d
Cleared Jan 27, 2003
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED,...
K022929 · MKJ
Cardiac Science, Inc.
Cardiovascular · 145d
Cleared Jan 27, 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · GEX
Candela Corp.
General & Plastic Surgery · 144d
Cleared Jan 27, 2003
SPEEDICATH
K023254 · GBM
Coloplast Corp.
Gastroenterology & Urology · 119d
Cleared Jan 27, 2003
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL:...
K023624 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 90d