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
19417–19440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2020
Accipiolx
K201310 · QAS
Maxq-Al , Ltd.
Radiology · 84d
Cleared Aug 07, 2020
EndoTool IV System
K201619 · NDC
Monarch Medical Technologies, LLC
Chemistry · 53d
Cleared Aug 07, 2020
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite...
K201883 · MBI
Medos International SARL
Orthopedic · 30d
Cleared Aug 07, 2020
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
K201926 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 28d
Cleared Aug 07, 2020
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
K201932 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Aug 07, 2020
LZI Fentanyl II Enzyme Immunoassay
K201938 · DJG
Lin-Zhi International, Inc.
Chemistry · 25d
Cleared Aug 06, 2020
TK Safety Needle
K191644 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 414d
Cleared Aug 06, 2020
Steripack cases and Tray Systems
K193066 · KCT
Avalign Technologies, Inc.
General Hospital · 276d
Cleared Aug 06, 2020
NHancer Rx
K200324 · DQY
Imds Operations B.V.
Cardiovascular · 178d
Cleared Aug 06, 2020
ManaFlow
K200353 · JOW
Manamed, Inc.
Cardiovascular · 175d
Cleared Aug 06, 2020
Mini Sterilizable Tray
K200858 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 127d
Cleared Aug 06, 2020
Invacare Perfecto2V Oxygen Concentrator
K200890 · CAW
Invacare Corporation
Anesthesiology · 125d
Cleared Aug 06, 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · QJP
Aqure Medical, Inc.
Neurology · 106d
Cleared Aug 06, 2020
VICRYL Mesh
K201143 · FTL
Ethicon, Inc.
General & Plastic Surgery · 99d
Cleared Aug 06, 2020
Vitra 810
K201502 · HQF
Quantel Medical
Ophthalmic · 62d
Cleared Aug 06, 2020
Medina Anterior Cervical Plate System
K201521 · KWQ
Alliance Partners, LLC
Orthopedic · 59d
Cleared Aug 06, 2020
Disposable Laparoscope Trocar
K201641 · GCJ
Beijing Biosis Healing Biolog Ical...
General & Plastic Surgery · 51d
Cleared Aug 06, 2020
Midmark Extraoral Imaging System (EOIS)
K201667 · OAS
Midmark Corporation
Radiology · 48d
Cleared Aug 06, 2020
Pentaray Nav eco High-Density Mapping Catheter
K201750 · MTD
Biosense Webster, Inc.
Cardiovascular · 41d
Cleared Aug 06, 2020
ClariVein IC
K201907 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Aug 05, 2020
NADIA SI Fusion System
K190580 · OUR
Ilion Medical, Inc.
Orthopedic · 518d
Cleared Aug 05, 2020
Enhanced External Counter Pulsation Device Plus Omay-A
K191955 · DRN
Omay(Guangzhou)Med Technologies Co.,...
Cardiovascular · 380d
Cleared Aug 05, 2020
Spartan Hip Stem
K192883 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 300d
Cleared Aug 05, 2020
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · JDB
Tornier, Inc.
Orthopedic · 254d