Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
74857–74880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2002
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT...
K022300 · ELM
Dental Vipi Ltda
Dental · 79d
Cleared Oct 03, 2002
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE...
K022475 · GEI
Arthrocare Corp.
General & Plastic Surgery · 66d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX
Datex-Ohmeda
Cardiovascular · 66d
Cleared Oct 03, 2002
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN...
K022808 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 41d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · LLZ
Acuson Corp.
Radiology · 30d
Cleared Oct 03, 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION...
K022904 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 30d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Oct 03, 2002
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND...
K022939 · DTE
Osypka Medical, Inc.
Cardiovascular · 29d
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