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
4945–4968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2025
TriALTIS™ Spine System
K243249 · NKB
Medos International SARL
Orthopedic · 98d
Cleared Jan 17, 2025
TBS iNsight (V4)
K243218 · KGI
Medimaps Group SA
Radiology · 105d
Cleared Jan 17, 2025
The ETHICON™ Total Energy System
K243067 · GEI
Ethicon Endo-Surgery, LLC (A Johnson...
General & Plastic Surgery · 112d
Cleared Jan 17, 2025
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · JOJ
True Indicating, LLC
General Hospital · 119d
Cleared Jan 17, 2025
Prenuvo Body Composition
K242825 · LNH
Prenuvo
Radiology · 121d
Cleared Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · LQY
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 126d
Cleared Jan 17, 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline...
K242705 · LDF
Medtronic, Inc.
Cardiovascular · 130d
Cleared Jan 17, 2025
Embozene Color-Advanced Microspheres
K242608 · KRD
Varian Medical Systems, Inc.
Gastroenterology & Urology · 136d
Cleared Jan 17, 2025
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · MRN
Airgas Therapeutics, LLC
Anesthesiology · 161d
Cleared Jan 17, 2025
hygh-tec Drainage II
K242336 · KNT
Amb Medtec
Gastroenterology & Urology · 163d
Cleared Jan 17, 2025
TechCare Trauma
K242171 · QBS
Milvue
Radiology · 177d
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