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
8953–8976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462 · LHQ
Usa Therm, Inc.
Radiology · 30d
Cleared Sep 14, 2023
OrionXR
K232189 · LLZ
Hoth Intelligence, Inc.
Radiology · 52d
Cleared Sep 14, 2023
Anovo Pedestal
K232146 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 57d
Cleared Sep 14, 2023
IPL Hair Removal, Model: W-1095, W-1098
K232124 · OHT
Shenzhen Wochuan Electronic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Sep 14, 2023
cNeuro cPET
K231576 · KPS
Combinostics OY
Radiology · 106d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484 · MMK
Pureway Compliance, Inc.
General Hospital · 114d
Cleared Sep 14, 2023
AccuCTP Pro
K231353 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 127d
Cleared Sep 14, 2023
Hammerdesis™ Interphalangeal Fusion System
K231147 · HTY
Intelivation
Orthopedic · 146d
Cleared Sep 14, 2023
LW Retraction Cap
K231079 · NHA
Ossvis Co., Ltd.
Dental · 150d
Cleared Sep 14, 2023
Cove Putty, OsteoCove Putty
K231030 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 156d
Cleared Sep 14, 2023
FlowStar Analog Mixer Flowmeter
K230987 · BZR
Baldus Sedation GmbH & Co. KG
Anesthesiology · 161d
Cleared Sep 14, 2023
VitreJect® Needle
K230959 · FMI
Ocuject, LLC
General Hospital · 163d
Cleared Sep 14, 2023
SOFIA EX Intracranial Support Catheter
K230775 · QJP
MicroVention, Inc.
Neurology · 177d
Cleared Sep 14, 2023
Non absorbable Surgical Polypropylene Suture
K230746 · GAW
Shandong Haidike Medical Products...
General & Plastic Surgery · 181d
Cleared Sep 14, 2023
TEA Device
K230526 · QHH
Transtimulation Research, Inc.
Gastroenterology & Urology · 199d
Cleared Sep 14, 2023
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7,...
K230237 · MQC
Hkable 3D Biologic Printing...
Dental · 227d
Cleared Sep 14, 2023
BACK 4
K230167 · IPF
Swims America Corp
Physical Medicine · 237d
Cleared Sep 14, 2023
Straumann® BLC and TLC Implants
K230108 · DZE
Institut Straumann AG
Dental · 244d
Cleared Sep 14, 2023
HOPKINS Telescopes
K223885 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 261d
Cleared Sep 14, 2023
ChoiceSpine Blackhawk Ti Cervical Spacer System
K223869 · OVE
Choice Spine, LLC
Orthopedic · 265d
Cleared Sep 14, 2023
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
K223833 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Sep 14, 2023
NEUROShield
K220034 · LLZ
In-Med Prognostics L3c
Radiology · 617d
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
Steris
General Hospital · 28d
Cleared Sep 13, 2023
GenX-CR
K232158 · MUH
Genoray Co., Ltd.
Radiology · 55d