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
74257–74280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 20d
Cleared Oct 02, 2002
BIOVER
K011208 · DXC
Biover AG
Cardiovascular · 531d
Cleared Oct 02, 2002
ENDIUS ATAVI SYSTEM
K022199 · HRX
Endius, Inc.
Orthopedic · 89d
Cleared Oct 02, 2002
CLEAN 'N' OIL
K022264 · EGS
Svenska Dental Instruments AB
Dental · 82d
Cleared Oct 02, 2002
LIGHT TIP
K022265 · EBZ
Svenska Dental Instruments AB
Dental · 82d
Cleared Oct 02, 2002
TOKUYAMA REBASE II
K022641 · EBI
Tokuyama America, Inc.
Dental · 55d
Cleared Oct 02, 2002
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER...
K022867 · JJY
Cliniqa Corporation
Chemistry · 35d
Cleared Oct 02, 2002
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
K022885 · JJY
Cliniqa Corporation
Chemistry · 33d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 02, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
K022936 · JJY
Cliniqa Corporation
Chemistry · 28d
Cleared Oct 02, 2002
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K022953 · MUH
Schick Technologies, Inc.
Radiology · 27d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966 · LWJ
Implex Corp.
Orthopedic · 26d
Cleared Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · FMF
Wrightmedicaltechnologyinc
General Hospital · 15d
Cleared Oct 02, 2002
BREATHABLE SURGICAL GOWN
K023167 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR...
K011493 · KPT
Mentor Corp.
Radiology · 504d
Cleared Oct 01, 2002
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 295d
Cleared Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · LOJ
Bayer Diagnostics Corp.
Immunology · 203d
Cleared Oct 01, 2002
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K021142 · EZL
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 175d
Cleared Oct 01, 2002
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K021389 · DQD
Andromed, Inc.
Cardiovascular · 152d
Cleared Oct 01, 2002
UNITY NETWORK ID
K021454 · MWI
General Electric Medical Systems...
Cardiovascular · 148d
Cleared Oct 01, 2002
QIVA
K021495 · DQK
Pie Medical Imaging BV
Cardiovascular · 145d
Cleared Oct 01, 2002
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
K022181 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Oct 01, 2002
I-STETHOS LINK
K022298 · DQD
Andromed, Inc.
Cardiovascular · 77d