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
21241–21264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2019
ZOLL Arrhythmia Management Sysyem
K190939 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 253d
Cleared Dec 19, 2019
Hereaeus Poseidon Microcatheter
K191305 · KRA
Heraeus Medical Components, LLC
Cardiovascular · 219d
Cleared Dec 19, 2019
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · HKY
Chongqing Sunkingdom Medical...
Ophthalmic · 218d
Cleared Dec 19, 2019
TK Sterile Hypodermic Needle
K191643 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 183d
Cleared Dec 19, 2019
4CIS Marlin PEEK ACIF Cage
K192044 · ODP
Solco Biomedical Co., Ltd.
Orthopedic · 141d
Cleared Dec 19, 2019
Aveta Disposable Hysteroscope
K192100 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 136d
Cleared Dec 19, 2019
Neodent Implant System- GM Titanium Base for Bridge
K192229 · NHA
Jjgc Industria E Comercio DE...
Dental · 125d
Cleared Dec 19, 2019
Halo One Thin-Walled Guiding Sheath
K192313 · DYB
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Dec 19, 2019
ZS3 and z.one pro Ultrasound Systems
K192410 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 106d
Cleared Dec 19, 2019
Everyway OTC TENS/EMS Combination
K192589 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Dec 19, 2019
LiteWalk
K192607 · IRP
Viasonix , Ltd.
Physical Medicine · 90d
Cleared Dec 19, 2019
Albumin BCP
K193001 · CJW
SENTINEL CH. SpA
Chemistry · 52d
Cleared Dec 19, 2019
Monopolar Cord
K193004 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 52d
Cleared Dec 18, 2019
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
K182476 · GDW
Fengh Medical Co., Ltd.
General & Plastic Surgery · 464d
Cleared Dec 18, 2019
OMNI-STAT Vascular (Rapid)
K190012 · QSY
Medtrade Product, Ltd.
General & Plastic Surgery · 349d
Cleared Dec 18, 2019
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway...
K190824 · CCK
Bluepoint Medical GmbH & Co. KG
Anesthesiology · 261d
Cleared Dec 18, 2019
IntraMarX Radiopaque Markers
K191087 · FFX
Anx Robotica Corp
Gastroenterology & Urology · 238d
Cleared Dec 18, 2019
BioSticker System
K191614 · DRG
Biointellisense, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2019
Electronic Stethoscope
K191667 · DQD
Hefei Mintti Medical Technology Co.,...
Cardiovascular · 180d
Cleared Dec 18, 2019
Sterile Latex Powder-Free Surgical Gloves
K191898 · KGO
Modern Healthcare Corp.
General Hospital · 155d
Cleared Dec 18, 2019
Avenir Complete Hip System, Size 0 Coxa Vara
K192189 · LZO
Zimmer, Inc.
Orthopedic · 127d
Cleared Dec 18, 2019
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K192580 · GAM
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Dec 18, 2019
BEACON Caresystem Model 00002144
K192584 · BZK
Mermaid Care A/S
Anesthesiology · 90d
Cleared Dec 18, 2019
Neodent Instrument Kit Cases
K192670 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 84d