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
70921–70944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2003
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
K030221 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 185d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766 · JDI
Smith & Nephew, Inc.
Orthopedic · 136d
Cleared Jul 25, 2003
THYRO TEST
K030912 · JLW
Thryotec
Chemistry · 123d
Cleared Jul 25, 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962 · KGI
Ge Lunar Corp.
Radiology · 120d
Cleared Jul 25, 2003
ELI 200+ AUDICOR
K031182 · DPS
Mortara Instrument, Inc.
Cardiovascular · 101d
Cleared Jul 25, 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · DTK
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Jul 25, 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · FMF
American Syringe Company
General Hospital · 84d
Cleared Jul 25, 2003
EXCEL PRIMARY SOLUTION SET
K031500 · FPA
Exelint Intl. Co.
General Hospital · 73d
Cleared Jul 25, 2003
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K031554 · CAC
Genzyme Biosurgery
Anesthesiology · 67d
Cleared Jul 25, 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
K031580 · LZA
Green Prospect Sdn Bhd
General Hospital · 66d
Cleared Jul 25, 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · DWF
Medtronic Perfusion Systems
Cardiovascular · 45d
Cleared Jul 25, 2003
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
K031854 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 39d
Cleared Jul 25, 2003
STAINLESS STEEL AQUATIC WHEELCHAIR
K031910 · IOR
Db Perks & Associates , Ltd.
Physical Medicine · 35d
Cleared Jul 25, 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959 · LXT
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 25, 2003
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
K031979 · FSY
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 29d
Cleared Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · HAW
Elekta Instrument AB
Radiology · 29d
Cleared Jul 25, 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 29d
Cleared Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · HAW
Elekta Instrument AB
Radiology · 28d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · HRY
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · KWQ
Aesculap, Inc.
Orthopedic · 23d
Cleared Jul 25, 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS,...
K032147 · FRN
Alaris Medical Systems, Inc.
General Hospital · 11d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182 · IYN
General Electric Co.
Radiology · 8d
Cleared Jul 24, 2003
MEGATECH SCIENTIFIC FACE MASK
K030239 · FXX
Megatech Scientific Pte, Ltd.
General Hospital · 182d
Cleared Jul 24, 2003
THERIFIL BONE FILLER
K031040 · MQV
Therics, Inc.
Orthopedic · 114d