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
27697–27720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2017
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
K172970 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 29d
Cleared Oct 25, 2017
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · FZP
AtriCure, Inc.
General & Plastic Surgery · 27d
Cleared Oct 25, 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse...
K173095 · NKB
Medos International SARL
Orthopedic · 26d
Cleared Oct 25, 2017
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope...
K173242 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 19d
Cleared Oct 24, 2017
Alinity c ICT Sample Diluent
K170320 · CGZ
Abbott Laboratories
Chemistry · 265d
Cleared Oct 24, 2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
K171575 · HQD
Contamac, Ltd.
Ophthalmic · 147d
Cleared Oct 24, 2017
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot...
K171751 · MWI
Capsule Technologie Sas
Cardiovascular · 133d
Cleared Oct 24, 2017
ClearLumen II Peripheral Thrombectomy System
K172000 · QEZ
Walk Vascular, LLC
Cardiovascular · 113d
Cleared Oct 24, 2017
UTS Stem
K172251 · LPH
United Orthopedic Corporation
Orthopedic · 90d
Cleared Oct 24, 2017
Dynamic Coronary Roadmap 2.0
K172307 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 85d
Cleared Oct 24, 2017
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
K172951 · MQB
Varex Imaging Corporation
Radiology · 28d
Cleared Oct 23, 2017
IRENE Cannulated Screw System
K170056 · HWC
Tianjin Zhengtian Medical Instrument...
Orthopedic · 290d
Cleared Oct 23, 2017
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · DHA
Abbott Laboratories
Chemistry · 264d
Cleared Oct 23, 2017
STERILE VINYL EXAMINATION GLOVES, Powder Free
K170612 · LYZ
Primus Gloves Pvt Limited
General Hospital · 236d
Cleared Oct 23, 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · GAM
Aesculap, Inc.
General & Plastic Surgery · 202d
Cleared Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K171277 · DRF
Innovative Health, LLC
Cardiovascular · 175d
Cleared Oct 23, 2017
G3™ Active Plate® Miniature System
K171293 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 174d
Cleared Oct 23, 2017
Acapella Cervical Spacer System
K171489 · OVE
Choicespine, LP
Orthopedic · 154d
Cleared Oct 23, 2017
M-ARS ACL: Anatomic Ribbon Surgery System
K171640 · MBI
Medacta International S.A.
Orthopedic · 143d
Cleared Oct 23, 2017
BeneLife Premium Facial Treatment Pack, Model: QZ0701A
K171647 · NFO
Infinitus (China) Company , Ltd.
Neurology · 140d
Cleared Oct 23, 2017
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · PML
Medtronic
Orthopedic · 117d
Cleared Oct 23, 2017
TruWave Disposable Pressure Transducer
K171996 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 112d
Cleared Oct 23, 2017
MECRON Cannulated Screw System
K172213 · HWC
Merete GmbH
Orthopedic · 91d
Cleared Oct 23, 2017
Lyme B. burgdorferi (IgM) MarStripe Test
K172254 · LSR
Trinity Biotech
Microbiology · 89d