FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121993–122016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1991
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
K904870 · KXA
Endotec, Inc.
Orthopedic · 212d
Cleared May 23, 1991
ALDETECT
K905779 · FJI
Pochemco, Inc.
Gastroenterology & Urology · 147d
Cleared May 23, 1991
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
K910563 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 104d
Cleared May 23, 1991
ONE STEP BUTTON(TM)
K910584 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 101d
Cleared May 23, 1991
TL100W/01 UVB LAMP
K910767 · FTC
Philips Lighting Co.
General & Plastic Surgery · 90d
Cleared May 23, 1991
SMALL INSTRUMENT STERILIZATION/BUR BOX
K910794 · EJL
Brevet, Inc.
Dental · 87d
Cleared May 23, 1991
STRYKER ARTHROSCOPIC INFUSION PUMP
K910858 · HRX
Stryker Corp.
Orthopedic · 84d
Cleared May 23, 1991
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · JDI
Howmedica Corp.
Orthopedic · 83d
Cleared May 23, 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · FRN
Abbott Laboratories
General Hospital · 79d
Cleared May 23, 1991
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM
K911197 · JWH
Orthomet, Inc.
Orthopedic · 66d
Cleared May 23, 1991
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY
K911198 · JWH
Orthomet, Inc.
Orthopedic · 66d
Cleared May 23, 1991
LM-150HT LIGHT SOURCE
K911212 · ESI
Leisegang Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 23, 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
K911438 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 51d
Cleared May 23, 1991
INNOFLUOR VALPROIC ACID CALIBRATOR SET
K911466 · DLJ
Intl. Bioclinical, Inc.
Chemistry · 50d
Cleared May 23, 1991
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · DJR
Bio-Rad
Toxicology · 22d
Cleared May 22, 1991
SPIROSIFT 500A
K904200 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
Cleared May 22, 1991
SERIES 7000 CARBON DIOXIDE MODULE
K904789 · CCK
Marquette Electronics, Inc.
Anesthesiology · 211d
Cleared May 22, 1991
CARDIOPULMONARY BYPASS PUMP TUBING
K910021 · DWF
Jtl Medical Corp.
Cardiovascular · 139d
Cleared May 22, 1991
ACTH IRMA KIT MITSUBISHI YUKA
K910178 · CKG
Science Regulatory Services Intl.
Chemistry · 127d
Cleared May 22, 1991
NEBU-SOL METERED DOSE DISPENSER (TM)
K910239 · BSY
Dey Laboratories, Inc.
Anesthesiology · 120d
Cleared May 22, 1991
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K910980 · HJO
Site Microsurgical Systems, Inc.
Ophthalmic · 76d
Cleared May 22, 1991
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · HNO
Storz Instrument Co.
Ophthalmic · 72d
Cleared May 22, 1991
OSMOMETER MODEL 2400
K911092 · JJM
Advanced Instruments, Inc.
Chemistry · 72d
Cleared May 22, 1991
HDL CHOLESTEROL REAGENT
K911406 · LBR
Genzyme Corp.
Chemistry · 54d