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
25681–25704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2018
PEDRA-17F Digital Flat Panel X-ray Detector
K180989 · MQB
Radisen, Inc.
Radiology · 58d
Cleared Jun 13, 2018
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K181050 · LPL
Qualimed Srl
Ophthalmic · 54d
Cleared Jun 13, 2018
Signature Orthodontic System
K181271 · NJM
Signature Orthodontics
Dental · 30d
Cleared Jun 13, 2018
Ysio Max
K181279 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Jun 13, 2018
Harmony XL Multi-Application Platform
K181298 · ONF
Alma Lasers, Inc.
General & Plastic Surgery · 28d
Cleared Jun 13, 2018
EcoVue Sterile and Non-Sterile Ultrasound Gels
K181363 · MUI
H R Pharmaceuticals, Inc.
Radiology · 21d
Cleared Jun 13, 2018
CELERITY 20 HP Biological Indicator
K181429 · FRC
STERIS Corporation
General Hospital · 12d
Cleared Jun 13, 2018
VERIFY Assert Self-Contained Biological Indicator
K181442 · OWP
STERIS Corporation
General Hospital · 12d
Cleared Jun 12, 2018
Access hs Tnl
K172783 · MMI
Beckman Coulter, Inc.
Chemistry · 270d
Cleared Jun 12, 2018
Portex NRFit Epidural Needles
K172823 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 267d
Cleared Jun 12, 2018
Perfusor® Space Syringe Infusion Pump System
K172831 · FRN
B.Braun Medical, Inc.
General Hospital · 267d
Cleared Jun 12, 2018
E-XPE Acetabular Components and U-Motion II Acetabular Cup
K172833 · OQI
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jun 12, 2018
ZQuiet
K180124 · LRK
Sleeping Well, LLC
Dental · 147d
Cleared Jun 12, 2018
Powder Free Vinyl Patient Examination Gloves (Yellow, White)
K180260 · LYZ
Shanxi Hongjin Plastic Technology...
General Hospital · 133d
Cleared Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 112d
Cleared Jun 12, 2018
SyMRI
K181093 · LNH
Syntheticmr AB
Radiology · 48d
Cleared Jun 12, 2018
HeartSee Cardiac P.E.T. Processing Software
K181343 · KPS
Bracco Diagnostics, Inc.
Radiology · 22d
Cleared Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · LZA
Ever Global (Vietnam) Enterprise Corp
General Hospital · 392d
Cleared Jun 11, 2018
Ti-one 101 TS Dental Implant System
K172821 · DZE
Hung Chun Bio-S Co., Ltd.
Dental · 266d
Cleared Jun 11, 2018
GRI-Alleset Veress Needle
K172835 · HIF
Gri Medical and Electronic Technology...
Obstetrics & Gynecology · 265d
Cleared Jun 11, 2018
LIAC HWL
K172961 · IYE
Sit Sordina Iort Technologies Spa
Radiology · 258d
Cleared Jun 11, 2018
SOFIA Plus Aspiration Catheter
K173200 · NRY
MicroVention, Inc.
Neurology · 252d
Cleared Jun 11, 2018
Pollogen Legend System
K173503 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 210d
Cleared Jun 11, 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage...
K173787 · MQP
Medos International SARL
General & Plastic Surgery · 179d