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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5593–5616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2024
Mako Shoulder Application (1.0)
K242373 · OLO
Mako Surgical Corp.
Orthopedic · 90d
Cleared Nov 07, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K242367 · PCH
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Nov 07, 2024
OZARK Cervical Plate System
K242361 · KWQ
Stryker Spine
Orthopedic · 90d
Cleared Nov 07, 2024
Remanufactured EndoWrist ProGrasp Forceps (420093)
K241872 · QSM
Rebotix
General & Plastic Surgery · 133d
Cleared Nov 07, 2024
Titanium Fletcher-Style Applicator Set Defined Geometry
K241853 · JAQ
Varian Medical Systems, Inc.
Radiology · 133d
Cleared Nov 07, 2024
NeuroICH
K241719 · QAS
Neurocareai, Inc.
Radiology · 146d
Cleared Nov 07, 2024
Vertiwedge® Intraosseous System
K241468 · MQP
Foundation Surgical Group, Inc.
Orthopedic · 167d
Cleared Nov 07, 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · MQB
Aspen Imaging Healthcare, Inc.
Radiology · 178d
Cleared Nov 07, 2024
icobrain aria
K240712 · QBS
Icometrix NV
Radiology · 237d
Cleared Nov 07, 2024
Trilogy Tissue Marker
K240429 · NEU
Inrad, Inc.
General & Plastic Surgery · 268d
Cleared Nov 07, 2024
Newclip Patient-matched instrumentation non sterile PSI
K240415 · PBF
Newclip Technics
Orthopedic · 269d
Cleared Nov 07, 2024
MicroTrend System
K212425 · CCK
Exostat Medical, Inc.
Anesthesiology · 1191d
Cleared Nov 06, 2024
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel)
K243222 · QDS
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 30d
Cleared Nov 06, 2024
Compound W Skin Tag Remover
K242803 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 50d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719 · PCC
Nu Eyne Co., Ltd.
Neurology · 57d
Cleared Nov 06, 2024
Agility Symmetric™ Total Knee System
K242412 · MBH
Medisurge, LLC
Orthopedic · 84d
Cleared Nov 06, 2024
Accelx Implant System
K242261 · DZE
Biotech Dental, LLC
Dental · 98d
Cleared Nov 06, 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB,...
K242039 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 117d
Cleared Nov 06, 2024
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997 · DQX
Abbott Medical
Cardiovascular · 209d
Cleared Nov 06, 2024
MultiCut Solo
K240831 · GCJ
Asclepion Laser Technologies GmbH
Obstetrics & Gynecology · 225d
Cleared Nov 06, 2024
Citrepore™
K240450 · MQV
Acuitive Technologies, Inc.
Orthopedic · 265d
Cleared Nov 05, 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 36d
Cleared Nov 05, 2024
Skyway Anterior Cervical Plate System
K243015 · KWQ
Kyocera Medical Technologies, Inc.
Orthopedic · 39d
Cleared Nov 05, 2024
FreedomFlow™ Orbital Circumferential Atherectomy System
K242947 · MCW
Cardio Flow Inc.,
Cardiovascular · 41d