FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4681–4704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2025
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
K242064 · NHA
Smart Denture Conversions, LLC
Dental · 186d
Cleared Jan 17, 2025
VersaD Delivery Catheter
K242051 · QJP
Unity Medical, Inc.
Neurology · 189d
Cleared Jan 17, 2025
Digital Color Doppler Ultrasound System (P60 Series)
K241949 · IYN
Sonoscape Medical Corp.
Radiology · 198d
Cleared Jan 17, 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 252d
Cleared Jan 17, 2025
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO...
K241269 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 268d
Cleared Jan 17, 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial...
K241261 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 266d
Cleared Jan 17, 2025
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and...
K241142 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 267d
Cleared Jan 17, 2025
cobas® liat CT/NG nucleic acid test
K240217 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 16, 2025
Medi Lift Mask
K244048 · NFO
Ya-Man, Ltd.
Neurology · 16d
Cleared Jan 16, 2025
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
K243885 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jan 16, 2025
Cala kIQ
K243848 · QBC
Cala Health, Inc.
Neurology · 31d
Cleared Jan 16, 2025
ADDNOX (BPSPM1)
K243289 · QGL
Nu Eyne Co., Ltd.
Neurology · 90d
Cleared Jan 16, 2025
WELLlife™ COVID-19 / Influenza A&B Home Test
K243256 · SCA
Wondfo USA Co., Ltd.
Microbiology · 93d
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Jan 16, 2025
Pearl Clear Aligner
K242715 · NXC
Pearl Digital, Inc.
Dental · 128d
Cleared Jan 16, 2025
Second Opinion CC
K242522 · MYN
Pearl, Inc.
Radiology · 146d
Cleared Jan 16, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10,...
K242416 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 154d
Cleared Jan 16, 2025
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K241736 · FRN
Deka Research and Development Corp.
General Hospital · 213d
Cleared Jan 16, 2025
CloudHRV™ System (100-01-001)
K241217 · DPS
Inmedix, Inc.
Cardiovascular · 260d
Cleared Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Jan 16, 2025
VIVIX-M
K241113 · MUE
Vieworks Co., Ltd.
Radiology · 269d
Cleared Jan 16, 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 16, 2025
Pepper EMS Training System
K233770 · NGX
Pepper Interactive, Inc.
Physical Medicine · 419d
Cleared Jan 15, 2025
EffortMed Spinal Fixation System
K243946 · NKB
Effortmed, LLC
Orthopedic · 26d