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
9697–9720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2023
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
K223100 · CAF
Medline Industries, Inc.
Anesthesiology · 270d
Cleared Jun 27, 2023
Hope&Her Vaginal Dilators
K222492 · HDX
Lujena, Inc.
Obstetrics & Gynecology · 314d
Cleared Jun 27, 2023
AceConnex Pre-Sutured Fascia
K213046 · GAT
Allosource
General & Plastic Surgery · 643d
Cleared Jun 26, 2023
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
K231215 · OHT
Zhongshan Qizhe Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Jun 26, 2023
ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113)
K230914 · GEI
ArthroCare Corporation
General & Plastic Surgery · 87d
Cleared Jun 26, 2023
Bone Bolt System
K230867 · HWC
University of Utah, Department of...
Orthopedic · 89d
Cleared Jun 26, 2023
Avitus® Precision Autograft Delivery System
K230492 · FMF
Avitus Orthopaedics, Inc.
General & Plastic Surgery · 123d
Cleared Jun 26, 2023
SAGICO Spinal System
K223143 · OVE
Sagico VA USA, LLC
Orthopedic · 265d
Cleared Jun 26, 2023
AB1 Electrosurgical Instrument, Creo Electrosurgical System
K223138 · NEY
Creo Medical, Ltd.
General & Plastic Surgery · 265d
Cleared Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · LON
bioMerieux, Inc.
Microbiology · 325d
Cleared Jun 26, 2023
Z7 Zirconia Implant System
K221488 · DZE
Z7, LLC
Dental · 399d
Cleared Jun 24, 2023
BR SLA Type Implant System
K222142 · DZE
Biotem Co., Ltd.
Dental · 339d
Cleared Jun 23, 2023
ActiGraph LEAP activity monitor (ActiGraph LEAP)
K231532 · LEL
Actigraph, LLC
Neurology · 28d
Cleared Jun 23, 2023
GORE® ACUSEAL Vascular Graft
K231505 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 30d
Cleared Jun 23, 2023
MapRT
K231185 · IYE
Vision Rt, Ltd.
Radiology · 58d
Cleared Jun 23, 2023
Neuhat Hair Growth System
K231153 · OAP
Nature, Inc.redible, Inc.
General & Plastic Surgery · 60d
Cleared Jun 23, 2023
neXus Ultrasonic Surgical Aspirator System
K231117 · LFL
Misonix, LLC, A Bioventus Company
General & Plastic Surgery · 64d
Cleared Jun 23, 2023
PERLA® TL System
K230774 · PML
Spineart
Orthopedic · 94d
Cleared Jun 23, 2023
HydraDose Vaginal Suppositories
K230518 · NUC
MD Labs, LLC
Obstetrics & Gynecology · 116d
Cleared Jun 23, 2023
DD medical polymers (PMMA)
K230410 · EBI
Dental Direkt GmbH
Dental · 128d
Cleared Jun 23, 2023
EUROPA™ Navigated Instruments
K230369 · OLO
MiRus, LLC
Orthopedic · 133d
Cleared Jun 23, 2023
KOH Ultramicro Injection Cannula (26167NN)
K230359 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 133d
Cleared Jun 23, 2023
TECHFIT DISRP® System
K230276 · DZJ
Techfit Digital Surgery
Dental · 142d
Cleared Jun 23, 2023
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86,...
K230160 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 155d