FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25729–25752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2018
Pakter Curved Needle Set
K173155 · BSP
Cook Incorporated
Anesthesiology · 251d
Cleared Jun 07, 2018
Tetric CAD
K173573 · EBF
Ivoclar Vivadent, AG
Dental · 199d
Cleared Jun 07, 2018
Guarded Luer Connector
K173577 · LHI
International Medical Industries, Inc.
General Hospital · 199d
Cleared Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122 · FTL
Medtronic, Inc.
General & Plastic Surgery · 142d
Cleared Jun 07, 2018
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188 · MQG
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 135d
Cleared Jun 07, 2018
VERASENSE for Zimmer Biomet Persona
K180459 · ONN
Orthosensor, Inc.
Orthopedic · 107d
Cleared Jun 07, 2018
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
K180612 · HSX
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 91d
Cleared Jun 07, 2018
AT 030
K180839 · HKY
Carl Zeiss Meditec, AG
Ophthalmic · 69d
Cleared Jun 07, 2018
Orthopantomograph OP 3D
K180947 · OAS
Palodex Group OY
Radiology · 57d
Cleared Jun 07, 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS...
K180956 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 56d
Cleared Jun 07, 2018
QLAB Advanced Quantification Software
K181264 · LLZ
Philips Ultrasound, Inc.
Radiology · 24d
Cleared Jun 06, 2018
VTRUST Vital Signs Monitor, Model: TD-2300
K172221 · MWI
Taidoc Technology Corporation
Cardiovascular · 317d
Cleared Jun 06, 2018
SD1 Ultrasonic Pocket Doppler
K172780 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 265d
Cleared Jun 06, 2018
POWDER FREE LATEX EXAMINATION GLOVE
K173053 · LYY
Professional Latex Sdn Bhd
General Hospital · 251d
Cleared Jun 06, 2018
ARK Fentanyl Assay
K180427 · DJG
ARK Diagnostics, Inc.
Toxicology · 110d
Cleared Jun 06, 2018
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System,...
K180436 · HSB
Stryker Trauma GmbH
Orthopedic · 106d
Cleared Jun 06, 2018
EchoMark, EchoMark LP
K180621 · NEU
Sonavex, Inc.
General & Plastic Surgery · 89d
Cleared Jun 06, 2018
Sterilization Pouch/Roll Made with Tyvek
K180672 · FRG
Sigma Medical Supplies Corporation
General Hospital · 84d
Cleared CT Jun 06, 2018
truSculpt RF Device
K180709 · PBX
Cutera, Inc.
General & Plastic Surgery · 79d
Cleared Jun 06, 2018
Coconut Infused Hybrid Personal Lubricant
K180712 · NUC
United Consortium
Obstetrics & Gynecology · 79d
Cleared Jun 06, 2018
SALVATION External Fixation System
K180832 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 68d
Cleared Jun 06, 2018
uMR 570
K180925 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 06, 2018
uMR 560
K180926 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 06, 2018
Sentry IVC Filter
K181202 · DTK
Novate Medical , Ltd.
Cardiovascular · 30d