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
4177–4200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2025
ChecQ (AC100)
K241065 · EKX
Dentis Co., Ltd.
Dental · 337d
Cleared Mar 21, 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · LHI
Yukon Medical, LLC
General Hospital · 366d
Cleared Mar 20, 2025
iSLEEVE Introducer Set
K250468 · DYB
Boston Scientific
Cardiovascular · 30d
Cleared Mar 20, 2025
Ameda GLO Wearable Breast Pump (Model W8S)
K250463 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Mar 20, 2025
RootMend MRR
K243988 · MBI
Riverpoint Medical, LLC
Orthopedic · 84d
Cleared Mar 20, 2025
Knee+
K243975 · SBF
Pixee Medical
Orthopedic · 87d
Cleared Mar 20, 2025
ViaOne Epicardial Access System
K243928 · DYB
Cardiovia , Ltd.
Cardiovascular · 90d
Cleared Mar 20, 2025
Revogene
K243922 · OOI
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Mar 20, 2025
brAIn™ Shoulder Positioning
K243292 · LLZ
Avatar Medical
Radiology · 153d
Cleared Mar 20, 2025
Starlight Imaging Catheter
K243016 · NQQ
Spectrawave, Inc.
Cardiovascular · 174d
Cleared Mar 20, 2025
Joylux Intimacy Gel (PG3100)
K242958 · NUC
Joylux, Inc.
Obstetrics & Gynecology · 176d
Cleared Mar 20, 2025
Tesera-k PL System and Tesera-k XL System
K242771 · MAX
Kyocera Medical Technologies, Inc.
Orthopedic · 188d
Cleared Mar 20, 2025
EXPD 114
K242770 · MQB
DRTECH Corporation
Radiology · 188d
Cleared Mar 20, 2025
Vent Creativity Knee v1.0 (Hermes)
K241961 · QIH
Vent Creativity
Radiology · 260d
Cleared Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884 · LPL
Hunan Haipuming Technology Co., Ltd.
Ophthalmic · 265d
Cleared Mar 20, 2025
Endoscopic Water Pump
K241704 · OCX
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 280d
Cleared Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series...
K250502 · LZA
Safesource Direct, LLC
General Hospital · 27d
Cleared Mar 19, 2025
DSPS-Prominent® baseplate, MR (113820)
K250429 · IYE
Macromedics BV
Radiology · 33d
Cleared Mar 19, 2025
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B,...
K250210 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 54d
Cleared Mar 19, 2025
IPL Hair Removal Device (BE965A, BE965B, BE965C)
K250171 · OHT
Shenzhen Yang WO Electronic Co., Ltd.
General & Plastic Surgery · 57d
Cleared Mar 19, 2025
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023,...
K250131 · OHT
Mustech Electronics Co., Limited
General & Plastic Surgery · 61d
Cleared Mar 19, 2025
PeekMed web
K250042 · QIH
Peek Health, S.A.
Radiology · 70d
Cleared Mar 19, 2025
TriMed Ankle Fixation System
K243999 · HRS
TriMed, Inc.
Orthopedic · 83d
Cleared Mar 19, 2025
TriMed Elbow and Forearm System
K243987 · HRS
TriMed, Inc.
Orthopedic · 86d