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
27073–27096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · LZA
Ansell Healthcare Products, LLC
General Hospital · 200d
Cleared Dec 29, 2017
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K172357 · LYZ
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 148d
Cleared Dec 29, 2017
Celerity 20 HP Biological Indicator
K172474 · FRC
STERIS Corporation
General Hospital · 136d
Cleared Dec 29, 2017
Reliance Cervical IBF System
K173102 · ODP
Reliance Medical Systems, LLC
Orthopedic · 91d
Cleared Dec 29, 2017
GEM Premier 5000
K173403 · CHL
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Dec 29, 2017
Medtronic O-arm O2 Imaging System
K173664 · OWB
Medtronic, Inc.
Radiology · 30d
Cleared Dec 28, 2017
Planmed Clarity
K163328 · MUE
Planmed OY
Radiology · 395d
Cleared Dec 28, 2017
MRSASelect II
K171061 · JSO
Bio-Rad
Microbiology · 262d
Cleared Dec 28, 2017
X-PSI Knee System
K171269 · JWH
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 241d
Cleared Dec 28, 2017
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide...
K172505 · DZE
Mis Implants Technologies , Ltd.
Dental · 132d
Cleared CT Dec 28, 2017
UroLift System (UL400 and UL500)
K173087 · PEW
Neotract, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 28, 2017
Piccolo Composite Nailing System
K173652 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 30d
Cleared Dec 27, 2017
COMPACT S, COMPACT S (LED)
K170104 · ELC
Dmetec.Co., Ltd.
Dental · 349d
Cleared Dec 27, 2017
PoreStar Patient Specific Implant
K171037 · JOF
Anatomics Pty, Ltd.
Ear, Nose, Throat · 265d
Cleared Dec 27, 2017
MEVION S250i Proton Beam Radiation Therapy Device
K172848 · LHN
Mevion Medical Systems
Radiology · 99d
Cleared Dec 27, 2017
Radiomics App v1.0
K173420 · LLZ
Microsoft Corp.
Radiology · 56d
Cleared Dec 26, 2017
NEURONAUTE
K170138 · GWQ
Bioserenity
Neurology · 343d
Cleared Dec 26, 2017
Real Time Image Gating System for Proton Beam Therapy Systems
K171049 · LHN
Hitachi, Ltd. Healthcare
Radiology · 263d
Cleared Dec 26, 2017
iLux Instrument, iLux Disposable
K172645 · ORZ
Tear Film Innovations, Inc.
Ophthalmic · 116d
Cleared Dec 26, 2017
IntelliVue Capnography Extension, IntelliVue Microstream Extension
K172904 · CCK
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 95d
Cleared Dec 26, 2017
SCS 17-01
K173008 · MQV
Anika Therapeutics, Inc.
Orthopedic · 90d
Cleared Dec 26, 2017
AltiVate Anatomic to Reverse Conversion Module
K173073 · PHX
Encore Medical, L.P.
Orthopedic · 88d
Cleared Dec 25, 2017
CoaguChek Vantus System
K170960 · GJS
Roche Diagnostics
Hematology · 269d
Cleared Dec 22, 2017
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators,...
K170993 · NXO
Inova Diagnostics, Inc.
Immunology · 263d