FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24049–24072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
K181902 · JXG
Integra Lifesciences Corp.
Neurology · 101d
Cleared Oct 25, 2018
DyeVert PLUS EZ Contrast Reduction System
K181936 · DXT
Osprey Medical, Inc.
Cardiovascular · 98d
Cleared Oct 25, 2018
Persona Revision Knee System
K181947 · JWH
Zimmer, Inc.
Orthopedic · 97d
Cleared Oct 25, 2018
SMV Scientific K-Wire and Pins
K182171 · JDW
Summit Medventures
Orthopedic · 76d
Cleared Oct 25, 2018
PeekMed
K182464 · LLZ
Peek Health, S.A.
Radiology · 45d
Cleared Oct 25, 2018
External upper limb tremor stimulator
K182706 · QBC
Cala Health, Inc.
Neurology · 28d
Cleared Oct 24, 2018
Monarch Airway Clearance System
K173603 · BYI
Hill-Rom Holdings, Inc.
Anesthesiology · 337d
Cleared Oct 24, 2018
Certus 140 2.45GHz Ablation System
K173756 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 317d
Cleared Oct 24, 2018
VAMP Optima closed blood sampling system
K180275 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™...
K180302 · MQF
Cook Incorporated
Obstetrics & Gynecology · 264d
Cleared Oct 24, 2018
GastroFlush
K180605 · KNT
Bionix Development Corporation
Gastroenterology & Urology · 231d
Cleared Oct 24, 2018
Osteocera Resorbable Bone Substitute
K180758 · MQV
Wiltrom Corporation Limited
Orthopedic · 216d
Cleared Oct 24, 2018
Gas Module 3
K180788 · BZK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 212d
Cleared Oct 24, 2018
KODEX EPD System
K180940 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 197d
Cleared Oct 24, 2018
World Total Knee System
K181530 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 135d
Cleared Oct 24, 2018
Cios Alpha
K181560 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 132d
Cleared Oct 24, 2018
Spine Wave Navigated Instruments
K181596 · OLO
Spine Wave, Inc.
Orthopedic · 128d
Cleared Oct 24, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K182140 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 78d
Cleared Oct 24, 2018
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT...
K182281 · IYO
C. R. Bard
Radiology · 62d
Cleared Oct 24, 2018
Retina Workplace
K182318 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 58d
Cleared Oct 24, 2018
Duo Lumbar Interbody Fusion Device
K182322 · MAX
Spineology, Inc.
Orthopedic · 58d
Cleared Oct 24, 2018
TempSure System
K182365 · GEI
Cynosure, Inc.
General & Plastic Surgery · 55d
Cleared Oct 24, 2018
GC70
K182647 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Oct 23, 2018
BD Single Use, Hypodermic Syringe
K172670 · FMF
Becton, Dickinson and Company
General Hospital · 413d