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
4993–5016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
K242229 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 169d
Cleared Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · QQX
Cepheid
Microbiology · 180d
Cleared Jan 15, 2025
Electrode Pad
K241512 · GXY
Shenzhen Deliduo Medical Technology...
Neurology · 231d
Cleared Jan 15, 2025
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
K241096 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 268d
Cleared Jan 14, 2025
Elegance® Anterior Cervical plate
K243904 · KWQ
Clariance
Orthopedic · 26d
Cleared Jan 14, 2025
Radical the Dude 8F Guide Catheter
K243577 · QJP
Maduro Medical, Inc.
Neurology · 56d
Cleared Jan 14, 2025
Orthoscan VERSA Mini C-Arm
K243452 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 68d
Cleared Jan 14, 2025
APRO 70 Swift Catheter
K243297 · QJP
Alembic, LLC
Neurology · 88d
Cleared Jan 14, 2025
LOCATOR Angled Abutment
K243272 · NHA
Zest Anchors, LLC
Dental · 90d
Cleared Jan 14, 2025
Zoom System
K242672 · NRY
Imperative Care, Inc.
Neurology · 130d
Cleared Jan 14, 2025
SpectoMed (v1.0)
K242205 · LLZ
Specto Medical
Radiology · 172d
Cleared Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
K241278 · PNG
Pfm Medical, Inc.
Gastroenterology & Urology · 253d
Cleared Jan 14, 2025
Consensus Knee System with TiNbN
K241180 · JWH
Shalby Advanced Technologies
Orthopedic · 260d
Cleared Jan 14, 2025
uCT 550
K241166 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 14, 2025
BB-613-BPM
K241066 · DXN
Biobeat Technologies , Ltd.
Cardiovascular · 271d
Cleared Jan 14, 2025
ABL90 FLEX PLUS System
K241037 · CEM
Radiometer Medicals Aps
Chemistry · 273d
Cleared Jan 13, 2025
ARVIS® Shoulder
K243950 · SBF
Kico Knee Innovation Company Pty, Ltd.
Orthopedic · 21d
Cleared Jan 13, 2025
Precision1
K243909 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 25d
Cleared Jan 13, 2025
Arthrex Intramedullary Nails
K243890 · HSB
Arthrex, Inc.
Orthopedic · 26d
Cleared Jan 13, 2025
Air Pressure Therapy System
K243791 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 34d
Cleared Jan 13, 2025
Sterilized Eol Auto Lancet
K243533 · FMK
Hlb Co., Ltd. Healthcare
General & Plastic Surgery · 59d
Cleared Jan 13, 2025
High Flow Insufflation Unit (UHI-4)
K243527 · HIF
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 60d
Cleared Jan 13, 2025
Initia Knee System
K243295 · JWH
Kyocera Medical Technologies, Inc.
Orthopedic · 87d
Cleared Jan 13, 2025
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer
K243271 · MRD
Mentor Worldwide, LLC
General & Plastic Surgery · 89d