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
26641–26664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2018
RTS Lesser MTP Implant System
K173491 · KWH
In2bones USA, LLC
Orthopedic · 102d
Cleared Feb 23, 2018
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
K173493 · FLE
STERIS Corporation
General Hospital · 102d
Cleared Feb 23, 2018
Ultrasound System 1300
K173569 · IYN
Bk Medical Aps
Radiology · 95d
Cleared Feb 23, 2018
InMode VLaze
K173677 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 85d
Cleared Feb 23, 2018
Ophthalmic Software Platform RX
K173689 · NFJ
Canon Inc. -Medical Equipment Group
Ophthalmic · 84d
Cleared Feb 23, 2018
Orbitum Bone Staple Implant, X and VI
K173693 · JDR
Orthovestments, LLC
Orthopedic · 84d
Cleared Feb 23, 2018
Ez3D-i /E3
K173863 · LLZ
Ewoosoft Co., Ltd.
Radiology · 65d
Cleared Feb 23, 2018
ELEOS™ Bipolar Acetabular System
K180130 · KWY
Onkos Surgical, Inc.
Orthopedic · 37d
Cleared Feb 22, 2018
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for...
K171171 · LZA
Koon Seng Sdn Bhd
General Hospital · 307d
Cleared Feb 22, 2018
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
K171568 · MQV
Hans Biomed Corporation
Orthopedic · 268d
Cleared Feb 22, 2018
The Panthera Anti-Snoring X3 Device
K171576 · LRK
Panthera Dental, Inc.
Dental · 268d
Cleared Feb 22, 2018
Straumann CARES M-Series CAD/CAM System
K171649 · NHA
Institut Straumann AG
Dental · 262d
Cleared Feb 22, 2018
U&U Indicator tape and strip
K171823 · JOJ
U&U Medical Technology Co, Ltd.
General Hospital · 248d
Cleared Feb 22, 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994 · LJS
Cook Incorporated
General Hospital · 234d
Cleared Feb 22, 2018
Osteotomy Truss System (OTS)
K172294 · HRS
4Web, Inc.
Orthopedic · 206d
Cleared Feb 22, 2018
Medline Catheter Specimen Collector
K172541 · EZD
Medline Industries, Inc.
Gastroenterology & Urology · 183d
Cleared Feb 22, 2018
LightForce LTS Model 1000, 1500, 2500, and 4000
K173067 · GEX
Litecure, LLC
General & Plastic Surgery · 146d
Cleared Feb 22, 2018
Sentry IVC Filter
K173236 · DTK
Novate Medical , Ltd.
Cardiovascular · 140d
Cleared Feb 22, 2018
Talon DistalFix Humeral Nail
K173255 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 135d
Cleared Feb 22, 2018
SeaSpine Spinous Process System
K173334 · PEK
SeaSpine Orthopedics Corporation
Orthopedic · 122d
Cleared Feb 22, 2018
Nexxis OR
K173381 · DXJ
Barco N.V.
Cardiovascular · 115d
Cleared Feb 22, 2018
Neocis Guidance System (NGS) with Chairside Splint
K173402 · PLV
Neocis, Inc.
Dental · 114d
Cleared Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer
K173485 · FLE
STERIS Corporation
General Hospital · 101d
Cleared Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
K173490 · FLE
STERIS Corporation
General Hospital · 101d