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
29665–29688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2017
ZipE Knotless Tissue Repair and Attachment Devices
K162429 · MAI
Ziptek, LLC
Orthopedic · 195d
Cleared Mar 13, 2017
mollosil plus
K162654 · EBI
Detax GmbH & Co. KG
Dental · 171d
Cleared Mar 13, 2017
FUJIFILM Surgical System
K162836 · GCJ
Fujifilm New Development U.S.A., Inc.
General & Plastic Surgery · 153d
Cleared Mar 13, 2017
Navigated Instrument System
K162921 · OLO
Orthofix, Inc.
Orthopedic · 146d
Cleared Mar 13, 2017
ORTHOLOC® 3Di Small Bones Plating
K163039 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 133d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Mar 13, 2017
NOVATECH TALCAIR
K170030 · GCJ
Novatech SA
General & Plastic Surgery · 68d
Cleared Mar 13, 2017
Thermi Injectable RF Electrodes
K170116 · GEI
Thermi
General & Plastic Surgery · 59d
Cleared Mar 11, 2017
PROLENE Soft Polypropylene Mesh
K163152 · FTL
Ethicon, Inc.
General & Plastic Surgery · 121d
Cleared Mar 10, 2017
Interstitial Needles
K160815 · JAQ
Varian Medical Systems, Inc.
Radiology · 351d
Cleared Mar 10, 2017
Infrared Non-contact Thermometer, Model ACT8100
K162509 · FLL
Easywell Biomedicals, Inc.
General Hospital · 183d
Cleared Mar 10, 2017
Adscope 658 Electronic Stethoscope
K162589 · DQD
American Diagnostic Corp.
Cardiovascular · 175d
Cleared Mar 10, 2017
iFuse Implant System® - iFuse-3D implant
K162733 · OUR
SI-BONE, Inc.
Orthopedic · 162d
Cleared Mar 10, 2017
RHYTHMIA HDx Mapping System
K162793 · DQK
Boston Scientific Corporation
Cardiovascular · 157d
Cleared Mar 10, 2017
Rapid2 Therapy System
K162935 · OBP
Magstim Company, Ltd.
Neurology · 141d
Cleared Mar 10, 2017
Mikro-Cath Pressure Catheter
K163376 · DXO
Millar, Inc.
Cardiovascular · 99d
Cleared Mar 10, 2017
CAVUX CervicalCage-L SA System
K163474 · OVE
Providence Medical Technology, Inc.
Orthopedic · 88d
Cleared Mar 10, 2017
AdvanCE capsule endoscope delivery device
K163495 · NEZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 10, 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · JJY
Aalto Scientific, Ltd.
Immunology · 78d
Cleared Mar 10, 2017
InterLock Trocar
K170084 · GCJ
Fujifilm New Development U.S.A., Inc.
General & Plastic Surgery · 59d
Cleared Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless...
K170336 · FOZ
Becton, Dickinson and Company
General Hospital · 36d
Cleared Mar 10, 2017
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist...
K170508 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Mar 10, 2017
Altus Spine Titanium Interbody Fusion System
K170512 · MAX
Altus Partners, LLC
Orthopedic · 17d
Cleared Mar 09, 2017
Transem and EchoGen Embryo Transfer Catheters
K161547 · MQF
Origio A/S
Obstetrics & Gynecology · 279d