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
28081–28104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2017
Navina Classic System
K170487 · KNT
Dentsply Sirona
Gastroenterology & Urology · 206d
Cleared Sep 11, 2017
TN-Brush
K170596 · ELB
Genoss Co., Ltd.
Dental · 195d
Cleared Sep 11, 2017
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved...
K170644 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 193d
Cleared Sep 11, 2017
da Vinci Xi EndoWrist Instruments and Accessories
K170645 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 193d
Cleared Sep 11, 2017
Electronic Caries Detector
K170822 · NBL
Ortek Therapeutics, Inc.
Dental · 175d
Cleared Sep 11, 2017
INVISION Total Ankle Revision System
K171067 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 154d
Cleared Sep 11, 2017
AIR-FLOW PLUS Prophylaxis powder
K171189 · EJR
E.M.S Electro Medical Systems S.A
Dental · 140d
Cleared Sep 11, 2017
Clear Vinyl Powder-free Patient Examination Gloves
K171317 · LYZ
Shandong Zhi Hong Medical Products,...
General Hospital · 130d
Cleared Sep 11, 2017
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow...
K171531 · KNW
Care Fusion
Gastroenterology & Urology · 109d
Cleared Sep 11, 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 60d
Cleared Sep 09, 2017
All-in-One Health Monitor, PC-303
K170047 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 247d
Cleared Sep 08, 2017
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
K163292 · BSP
Spectra Medical Devices
Anesthesiology · 290d
Cleared Sep 08, 2017
hemochroma PLUS System
K163465 · GKR
Immunostics Inc.,
Hematology · 270d
Cleared Sep 08, 2017
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava...
K163699 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 253d
Cleared Sep 08, 2017
BePOD® EZ Weil Screws
K163710 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 252d
Cleared Sep 08, 2017
QMAPP Amplifier
K170032 · MWI
Fysicon BV
Cardiovascular · 247d
Cleared Sep 08, 2017
Medline Hemo-Force DVT Compression Sleeve
K170415 · JOW
Medline Industries, Inc.
Cardiovascular · 210d
Cleared Sep 08, 2017
The Locking Pediatric Osteotomy Plate (LolliPOP) System
K170704 · KTT
Pega Medical, Inc.
Orthopedic · 184d
Cleared Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · LCO
Instrumentation Laboratory CO
Hematology · 170d
Cleared Sep 08, 2017
014 Hydrophilic Coated PTA Balloon Dilatation Catheter
K171251 · LIT
Creagh Medical
Cardiovascular · 133d
Cleared Sep 08, 2017
Nanova Sealant
K171330 · EBC
Nanova Biomaterials, Inc.
Dental · 126d
Cleared CT Sep 08, 2017
Indego
K171334 · PHL
Parker Hannifin Corporation
Neurology · 123d
Cleared Sep 08, 2017
Posterior Spine Truss System (PSTS) Interbody Fusion Device
K171351 · MAX
4Web, Inc.
Orthopedic · 122d
Cleared Sep 08, 2017
Footmotion Plating System
K171510 · HRS
Newclip Technics
Orthopedic · 107d