Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
34753–34776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2015
Elevate Moisturizing Spray
K150074 · LFD
Elevate Oral Care
Dental · 156d
Cleared Jun 19, 2015
PreludeEASE Hydrophilic Sheath Introducer
K150257 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 136d
Cleared CT Jun 19, 2015
miraDry System MD4000
K150419 · OUB
Miramar Labs, Inc.
General & Plastic Surgery · 121d
Cleared Jun 19, 2015
Px PEEK IBF System
K150500 · MAX
Innovasis, Inc.
Orthopedic · 113d
Cleared Jun 19, 2015
Life Fast Set, Life Regular Set
K150559 · EJK
Sybron Dental Specialties
Dental · 105d
Cleared Jun 19, 2015
Tissue Removal Pouch
K150781 · GCJ
Boehringer Laboratories, LLC
General & Plastic Surgery · 86d
Cleared Jun 19, 2015
SPEC Model M16
K150895 · KXK
Source Production and Equipment Co.,...
Radiology · 78d
Cleared Jun 19, 2015
PRECICE Intramedullary Limb Lengthening System
K151131 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 52d
Cleared Jun 19, 2015
Arthrex FiberTak Anchors
K151230 · MBI
Arthrex, Inc.
Orthopedic · 42d
Cleared Jun 18, 2015
Infusomat Space Volumetric Infusion Pump
K142596 · FRN
B.Braun Medical, Inc.
General Hospital · 276d
Cleared Jun 18, 2015
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation...
K142752 · NKB
Zimmer Spine, Inc.
Orthopedic · 267d
Cleared Jun 18, 2015
I.V. Catheter
K142797 · FOZ
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 262d
Cleared Jun 18, 2015
iPulse Smooth Skin Gold Hair Removal System
K143003 · OHT
Ipulse Limited
General & Plastic Surgery · 241d
Cleared Jun 18, 2015
NanoKnife System
K150089 · OAB
AngioDynamics, Inc.
General & Plastic Surgery · 153d
Cleared Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
K150113 · LZA
Halyard Health
General Hospital · 149d
Cleared Jun 18, 2015
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue),...
K150340 · LZA
Hebei Hongsen Plastics Technology Co,...
General Hospital · 127d
Cleared Jun 18, 2015
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with...
K150369 · PLC
Somnomed, Inc.
Dental · 125d
Cleared Jun 18, 2015
Nanova Flowable Composite
K150623 · EBF
Nanova Biomaterials, Inc.
Dental · 99d
Cleared Jun 18, 2015
Safety Disposable Insulin Syringe
K150758 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 87d
Cleared Jun 18, 2015
XIDF-AWS801, Angio Workstation, V6.10
K150967 · OWB
Toshibamedical Systems Corporation
Radiology · 66d
Cleared Jun 18, 2015
LOGIQ e
K151028 · IYN
GE Medical Systems Ultrasound and...
Radiology · 62d
Cleared Jun 18, 2015
DePuy Synthes T-PAL Ti Spacer
K151276 · MAX
Synthes USA Products, LLC
Orthopedic · 36d
Cleared Jun 18, 2015
Spacemaker Pro Access and Dissector System
K151356 · GCJ
Covidien, LLC
General & Plastic Surgery · 29d
Cleared Jun 17, 2015
ZIBONE ZIRCONIA BLOCKS
K140836 · EIH
Coho Technology Co., Ltd.
Dental · 441d