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
71425–71448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2003
MIX2VIAL TRANSFER DEVICE
K031861 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 43d
Cleared Jul 29, 2003
VIRTUOSAPH
K031891 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 46d
Cleared Jul 29, 2003
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
K032062 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 26d
Cleared Jul 28, 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · MGQ
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 209d
Cleared Jul 28, 2003
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K030170 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 192d
Cleared Jul 28, 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · DZE
Implant Innovations, Inc.
Dental · 80d
Cleared Jul 28, 2003
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · QPB
Biosculpture Technology, Inc.
General & Plastic Surgery · 40d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 32d
Cleared Jul 28, 2003
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50...
K032007 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 28d
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