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

Filters: Cleared only ×
175,820 results
27913–27936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2017
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B...
K171792 · OCC
Alere Scarborough, Inc.
Microbiology · 105d
Cleared Sep 29, 2017
Thommen Implant System
K171795 · DZE
Thommen Medical AG
Dental · 105d
Cleared Sep 29, 2017
SCARLET AC-T
K172065 · ODP
Spineart
Orthopedic · 84d
Cleared Sep 29, 2017
Photoelectric Therapy System
K172080 · JAD
Xstrahl, Ltd.
Radiology · 81d
Cleared Sep 29, 2017
Endoscopic Ultrasound Aspiration Needle
K172309 · ODG
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Sep 29, 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · IYN
Ge Healthcare
Radiology · 58d
Cleared Sep 29, 2017
U2 Diagnostic Ultrasound System
K172380 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
K172397 · LJS
C.R. Bard, Inc.
General Hospital · 52d
Cleared Sep 29, 2017
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use...
K172420 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 50d
Cleared Sep 29, 2017
Arisure Dry Spike
K172631 · LHI
Yukon Medical
General Hospital · 28d
Cleared Sep 28, 2017
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
K161434 · OLP
Li-Tek Electronics Technologies
General & Plastic Surgery · 492d
Cleared Sep 28, 2017
Single Use Micro Electrode (Brass with gold plated shaft)
K163442 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 294d
Cleared Sep 28, 2017
SurgiCube
K163455 · ORC
Surgicube International B.V.
General Hospital · 293d
Cleared Sep 28, 2017
Peel-Away Introducer Set
K170020 · DYB
Cook Incorporated
Cardiovascular · 268d
Cleared Sep 28, 2017
Digital Thermometer
K170262 · FLL
K-Jump Health Co., Ltd.
General Hospital · 244d
Cleared Sep 28, 2017
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
K170498 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 223d
Cleared CT Sep 28, 2017
TRAUMACEM™ V+ Injectable Bone Cement
K170802 · LOD
Synthes USA Products, LLC
Orthopedic · 195d
Cleared Sep 28, 2017
AirFit N20
K171212 · BZD
Resmed, Ltd.
Anesthesiology · 156d
Cleared Sep 28, 2017
NuVasive TLX Interbody System
K171633 · MAX
Nu Vasive, Incorporated
Orthopedic · 118d
Cleared Sep 28, 2017
MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
K171728 · DZE
Sterngold Dental, LLC
Dental · 108d
Cleared Sep 28, 2017
NuVasive® Precept™ Spinal System
K171894 · NKB
Nu Vasive, Incorporated
Orthopedic · 94d
Cleared Sep 28, 2017
Anatotemp Anatomic Dental Implant Healing Abutment
K171922 · NHA
Buckeye Medical Technologies, LLC
Dental · 93d
Cleared Sep 28, 2017
Resection Electrodes with HF cable
K171965 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Sep 28, 2017
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 30d