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
10513–10536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2023
Vinyl examination gloves
K230046 · LYZ
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 78d
Cleared Mar 24, 2023
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button...
K220212 · JKA
Becton, Dickinson and Company
General Hospital · 422d
Cleared Mar 24, 2023
Starly pad
K221589 · GXY
Shenzhen Xingyuanli Technology Co., Ltd.
Neurology · 296d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559 · MDB
Becton, Dickinson and Company
Microbiology · 212d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591 · MDB
Becton, Dickinson and Company
Microbiology · 210d
Cleared Mar 24, 2023
BD Texium™ Closed Male Luer
K223076 · ONB
Care Fusion
General Hospital · 175d
Cleared Mar 24, 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · FXX
Medline Industries, LP
General Hospital · 156d
Cleared Mar 24, 2023
Blood Collection Needle (with/without Needle Holder)
K223323 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 144d
Cleared Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K223803 · QPP
Canary Medical USA, LLC
Orthopedic · 95d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Entarik Feeding Tube System
K230206 · KNT
Gravitas Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 24, 2023
3 Series NeoLux
K230382 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 39d
Cleared Mar 24, 2023
Quantra Hemostasis Analyzer
K230461 · QFR
Hemosonics, LLC
Hematology · 31d
Cleared Mar 24, 2023
EVA5 Insufflator
K230474 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 23, 2023
VHT-200 Wound Treatment System
K212121 · KPJ
Vaporox, Inc.
General & Plastic Surgery · 624d
Cleared Mar 23, 2023
Sterile Hypodermic Syringe for Single Use
K212207 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 616d
Cleared Mar 23, 2023
Implant-One Multi-Unit Abutment
K212394 · NHA
Implant Logistics, Inc.
Dental · 598d
Cleared Mar 23, 2023
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice...
K221585 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 295d
Cleared Mar 23, 2023
AccurSound Electronic Stethoscope AS-101
K221805 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 274d
Cleared Mar 23, 2023
Endo Ultrasonic Activator
K222096 · ELC
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 248d
Cleared Mar 23, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · NKB
OrthoPediatrics Corp.
Orthopedic · 248d
Cleared Mar 23, 2023
Sterilization Wrap
K222151 · FRG
Kenpax International Limited
General Hospital · 246d
Cleared Mar 23, 2023
MeMed BV
K222332 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 233d