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
25657–25680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2018
Ligation Device
K172985 · FHN
Leo Medical Co., Ltd.
Gastroenterology & Urology · 260d
Cleared Jun 14, 2018
ASI Evolution
K173376 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 227d
Cleared Jun 14, 2018
SurgTech Bipolar Head System
K173455 · KWY
Surgtech, Inc.
Orthopedic · 219d
Cleared Jun 14, 2018
EchoMD Automated Ejection Fraction Software
K173780 · LLZ
Bay Labs, Inc.
Radiology · 184d
Cleared Jun 14, 2018
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP...
K173977 · DQK
Biosense Webster, Inc.
Cardiovascular · 167d
Cleared Jun 14, 2018
MRIaudio PREM System
K180100 · LNH
Mriaudio
Radiology · 149d
Cleared Jun 14, 2018
Natus Brain Monitor Amplifier
K180290 · GWQ
Natus Medical Incorporated Dba...
Neurology · 133d
Cleared Jun 14, 2018
TiWAVE-C™ Porous Titanium Cervical Cage
K180401 · ODP
Kalitec Direct, LLC
Orthopedic · 120d
Cleared Jun 14, 2018
S128 Anterior Lumbar Interbody Fusion (ALIF) System
K180502 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 108d
Cleared Jun 14, 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with...
K180505 · LZA
Hartalega Sdn Bhd
General Hospital · 108d
Cleared Jun 14, 2018
InMode Diolaze System
K180719 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 87d
Cleared Jun 14, 2018
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent...
K180738 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 14, 2018
BTL 799-2
K180813 · NGX
BTL Industries, Inc.
Physical Medicine · 77d
Cleared Jun 14, 2018
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280 · KRR
Arthrosurface, Inc.
Orthopedic · 30d
Cleared Jun 14, 2018
Smart External Drain (SED) System
K181301 · JXG
Aqueduct Critical Care, Inc.
Neurology · 28d
Cleared Jun 14, 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · NBW
Intuity Medical, Inc.
Chemistry · 27d
Cleared Jun 14, 2018
Double Flexible Tipped Wire Guides
K181351 · DQX
Cook Incorporated
Cardiovascular · 23d
Cleared Jun 13, 2018
HealthCCS
K172983 · JAK
Zebra Medical Vision, Ltd.
Radiology · 259d
Cleared Jun 13, 2018
Case Medical SteriTite Reusable Rigid Sterilization Container System with...
K173259 · KCT
Case Medical, Inc.
General Hospital · 246d
Cleared Jun 13, 2018
PEAK NS033CF, PEAK NS017CF
K180565 · ELW
Neosil Co., Ltd.
Dental · 100d
Cleared Jun 13, 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · ODP
Atlas Spine, Inc.
Orthopedic · 90d
Cleared Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
K180681 · LSL
Hologic, Inc.
Microbiology · 90d
Cleared Jun 13, 2018
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
K180818 · OUR
Tenon Medical, Inc.
Orthopedic · 76d
Cleared Jun 13, 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180861 · LYZ
Zhicheng Trading Co., Ltd.
General Hospital · 72d