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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
33529–33552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2015
PULLUP® Adjustable Juxtacortical Fixation Device
K151004 · MBI
Sbm Sciences For Bio Materials
Orthopedic · 216d
Cleared Nov 17, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151682 · LYZ
Daxwell, LLC
General Hospital · 148d
Cleared Nov 17, 2015
Nanova Universal Composite
K152004 · EBF
Nanova Biomaterials, Inc.
Dental · 120d
Cleared Nov 17, 2015
Renaissance X System
K152041 · OLO
Mazor Robotics , Ltd.
Orthopedic · 118d
Cleared Nov 17, 2015
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
K152318 · IYO
MEDA Co., Ltd.
Radiology · 92d
Cleared Nov 17, 2015
TYRX Neuro Antibacterial Envelope
K152678 · FTL
Tyrx, Inc.
General & Plastic Surgery · 60d
Cleared Nov 17, 2015
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
K152847 · PGY
Qubyx , Ltd.
Radiology · 49d
Cleared Nov 17, 2015
AUTOLAP SYSTEM
K152848 · GCJ
M.S.T Medical Surgery Technologies, Ltd.
General & Plastic Surgery · 49d
Cleared Nov 17, 2015
RANGE/DENALI/MESA Spinal System
K153031 · NKB
K2m, Incorporated
Orthopedic · 29d
Cleared Nov 16, 2015
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR...
K150504 · PSW
Pci Medical, Inc.
General Hospital · 263d
Cleared Nov 16, 2015
Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
K150609 · KGO
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612 · LYY
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · LPH
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Nov 16, 2015
KYPHON XPEDE Bone Cement
K151227 · NDN
Medtronic
Orthopedic · 193d
Cleared Nov 16, 2015
ICS Impulse
K151504 · GWN
Gn Otometrics
Neurology · 165d
Cleared Nov 16, 2015
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
K151605 · KGO
Lucenxia Prescience AG
General Hospital · 154d
Cleared Nov 16, 2015
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K151607 · KGO
Lucenxia Prescience AG
General Hospital · 154d
Cleared Nov 16, 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · NHA
Prismatik Dentalcraft, Inc.
Dental · 137d
Cleared Nov 16, 2015
Viradius Neurowire
K151825 · MOF
Mivi Neuroscience, Inc.
Neurology · 133d
Cleared Nov 16, 2015
HairMD
K152019 · OAP
Trophy Skin, Inc.
General & Plastic Surgery · 118d
Cleared Nov 16, 2015
Arthrex iBalance TKA System
K152252 · MBH
Arthrex, Inc.
Orthopedic · 98d
Cleared Nov 16, 2015
BoneCam Suture Anchors
K152255 · MBI
Valeris Medical
Orthopedic · 98d
Cleared Nov 16, 2015
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular...
K152298 · MBH
Microport Orthopedics, Inc.
Orthopedic · 95d
Cleared Nov 16, 2015
HICAT Air
K152661 · LLZ
Hicat GmbH
Radiology · 60d