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
27337–27360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 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
Cleared Sep 28, 2017
FiberTak DX
K172612 · MBI
Arthex, Inc.
Orthopedic · 28d
Cleared Sep 28, 2017
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU -...
K172659 · GAM
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 23d
Cleared Sep 27, 2017
Cetus system, Cetus probe
K170183 · HQE
A.R.C Laser GmbH
Ophthalmic · 247d
Cleared Sep 27, 2017
Spider Frame External Fixation System
K170482 · KTT
Tasarimmed Tibbi Mamuller Sanayi VE...
Orthopedic · 223d
Cleared Sep 27, 2017
CRYOFOS
K170810 · GEH
Cryofos Medical GmbH
General & Plastic Surgery · 194d
Cleared Sep 27, 2017
OIC External Fixation System
K171211 · KTT
Orthopaedic Implant Company
Orthopedic · 155d
Cleared Sep 27, 2017
QiF Blood and Fluid Warmer
K171215 · LGZ
Quality IN Flow , Ltd.
General Hospital · 155d
Cleared Sep 27, 2017
Scopis Extended Instrument Set EM
K171661 · PGW
Scopis GmbH
Ear, Nose, Throat · 114d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 91d
Cleared Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
K172109 · JWY
Liofilchem S. R. L.
Microbiology · 76d
Cleared Sep 27, 2017
Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
K172275 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 61d
Cleared Sep 26, 2017
Vesco Medical Nasoenteric Feeding Tubes
K170162 · PIF
Vesco Medical, LLC
Gastroenterology & Urology · 251d
Cleared Sep 26, 2017
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine...
K170816 · LLZ
Brainlab AG
Radiology · 190d