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
8209–8232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2023
Medline ComfortTemp Patient Warming System
K231211 · DWJ
Medline Industries, LP
Cardiovascular · 217d
Cleared Dec 01, 2023
Slinky Catheter
K231179 · QJP
Anoxia Medical, Inc.
Neurology · 219d
Cleared Dec 01, 2023
Antibacterial Gel Wound Dressing
K231057 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 232d
Cleared Dec 01, 2023
Vial2Bag Advanced® 13mm Admixture Device
K230988 · LHI
West Pharma Services Il, Ltd.
General Hospital · 239d
Cleared Dec 01, 2023
Align Cervical Interbody Fusion System
K230639 · ODP
Acuity Surgical Devices, LLC
Orthopedic · 268d
Cleared Dec 01, 2023
LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
K230621 · GEI
Surgical Principals, Inc.
General & Plastic Surgery · 270d
Cleared Dec 01, 2023
Extension Set
K230528 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 277d
Cleared Dec 01, 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™...
K230391 · JKA
Becton, Dickinson and Company
Chemistry · 290d
Cleared Nov 30, 2023
IDEAL Ziploop
K233552 · MBI
Riverpoint Medical
Orthopedic · 27d
Cleared Nov 30, 2023
EPIQ Series Diagnostic Ultrasound System
K233545 · IYN
Philips Ultrasound, LLC
Radiology · 27d
Cleared Nov 30, 2023
14F iSLEEVE Introducer Set
K233503 · DYB
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Nov 30, 2023
Benesta Tissue Removal Device
K233500 · HIH
Caldera Medical, Inc.
Obstetrics & Gynecology · 30d
Cleared Nov 30, 2023
Q-Switched Nd:Yag laser
K232716 · GEX
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 30, 2023
Diode laser therapy device
K232709 · GEX
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 30, 2023
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
K232611 · MAX
Life Spine, Inc.
Orthopedic · 94d
Cleared Nov 30, 2023
LumenEye® X1 endoscope (LX1-SCP-203)
K232262 · FAN
Surgease Innovations Limited
Gastroenterology & Urology · 122d
Cleared Nov 30, 2023
syngo.CT Dual Energy
K232155 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Nov 30, 2023
NavaClick Injection System
K231877 · FMF
Lineage Biomedical, Inc.
General Hospital · 157d
Cleared Nov 30, 2023
Somfit
K231546 · MNR
Compumedics Limited
Neurology · 184d
Cleared Nov 30, 2023
Radical the Dude 7F Guide Catheter
K231393 · QJP
Maduro Medical, Inc.
Neurology · 202d
Cleared Nov 30, 2023
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
K230669 · LJS
Argon Medical Devices
General Hospital · 265d
Cleared Nov 30, 2023
Wrist Pulse Oximeter
K230587 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 273d
Cleared Nov 30, 2023
Insulin Syringe
K230061 · FMF
Anhui Hongyu Wuzhou Medical...
General Hospital · 325d
Cleared Nov 30, 2023
Auxein's DHS/DCS Plate System
K221787 · KTT
Auxein Medical Private Limited
Orthopedic · 527d