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
Broncoflex Agile, Broncoflex Vortex, Screeni
Axess Vision Technology
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use
Anhui Deepblue Medical Technology Co., Ltd.
Conductive carbon film electrode
Guangzhou Xinbo Electronic Co., Ltd.
ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long S
Ethicon Endo-Surgery, LLC
NuVasive Modulus-C Interbody System
Nuvasive, Inc.
ExactechGPS® System
Blue Ortho
Chemo Mouthpiece
Chemo Mouthpiece, LLC
Assure Titanium Blood Glucose Monitoring System
Arkray, Inc.
AROMA GRAND
Daeju Meditech Engineering Co., Ltd.
Elecsys CMV IgG
Roche Diagnostics
MIS LYNX Conical Connection Implant System
Dentsply Sirona, Inc.
DNA/RNA Shield SafeCollect Saliva Collection kit
Zymo Research
Anika Tissue Tack Fixation System
Anika Therapeutics, Inc.
Caretaker Platform, VitalStream Platform, CT5
Caretaker Medical
OPTRELL Mapping Catheter with TRUEref Technology
Biosense Webster, Inc.
Deep Learning Image Reconstruction
Ge Healthcare Japan Corporation
Neuronaute with IceCap 2 & IceCap 2 Small
Bioserenity
LightStrike+ (MXSUV1-SL and MXSUV1-FT)
Xenex Disinfection Services, Inc.
Pressio 3 Multi-parameter Neuromonitoring System
Sophysa
CardioCurve Steerable Sheath
Talon Surgical
EarliPoint
Earlitec Diagnostics, Inc.
Biosci Inactivated Transport Medium, Biosci ITM
Shenzhen Dakewe Bio-Engineering Co., Ltd.
S-Plant Dental Implant System
Idis Co., Ltd.
Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (R
Centerline Biomedical, Inc.
Access Ostase
Beckman Coulter
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
Zsfab, Inc.
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
Shenzhen Nuon Medical Equipment Co., Ltd.
DRX - Compass
Carestream Health, Inc.
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
Braincare Desenvolvimento E Inovação Tecnológica S.A.
Clear Aligner
Shenzhen Meiming Dentistry Technology Co., Ltd.
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