510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
DeGen Medical Patient Specific Implant (PSI) System
Degen Medical
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
MED-EL Elektromedizinische Geräte GmbH
Magnetic Surgical System
Levita Magnetics International Corp
NUVENTUS NV.C Dental Implant System
Infinitum Eta, Ltd.
AeviceMD
Aevice Health Pte. , Ltd.
Access NT-proBNP
Beckman Coulter, Inc.
Access BNP II
Beckman Coulter, Inc.
Radiation Planning Assistant (RPA)
University of Texas, MD Anderson Cancer Center
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc.
MatriDerm pluS+ Bi-Layer
Medskin Solutions Dr. Suwelack AG
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 1
Ximedica
EasyOne Filter
Ndd Medizintechnik AG
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
O&M Halyard, Inc.
Low Profile Companion Sheath
Merit Medical Systems, Inc.
OsteoCool 2.0 RF Ablation System
Medtronic Sofamor Danek USA, Inc.
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Xiantao Zhibo Non-Woven Products Co., Ltd.
Masimo W1
Masimo Corporation
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
23AndMe, Inc.
Clear Aligner (SCF-3348)
Beame Medical Technology (Shenzhen) Limited
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
Maxx Orthopedics, Inc.
HELIOS 785 Pico
Laseroptek Co., Ltd.
Promisemed Safety Huber Needle
Promisemed Hangzhou Meditech Co., Ltd.
Unity Total Knee System
Corin U.S.A. Limited
Infrared Thermometer, Model: IR8807
Shen Zhen Rong Feng Technology Co., Ltd.
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Th
Covidien, LLC
Giftlife® Single-Step Medium Plus
Gimbo Medical Technology Shenzhen Co., Ltd.
NOABLE LASER
Daeju Meditech Engineering Co., Ltd.
Cystatin C
SENTINEL CH. SpA
CORE-SPORT
Incore Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert