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
Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment Co., Ltd.
Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Nee
Jiangsu Micsafe Medical Technology Co., Ltd.
TENS device-HeadaTerm 2 (Model: YF-HT2)
Wat Medical Technology, Inc.
Pentax Medical Valve Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
Atmos Medizintechnik GmbH & Co. KG
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
Zevex, Inc.
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Owl Night Guard
Owl Dental Lab, Inc.
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) Syst
Dexcom, Inc.
FibriCheck
Qompium NV
Artisan Bone Plug, Universal Cement Restrictor
Howmedica Osteonics, Dba Stryker Orthopaedics
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
Hangzhou AllTest Biotech Co., Ltd.
Sterile PHALINX Hammertoe System
Wrightmedicaltechnologyinc
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
Compact II
Enraf-Nonius, B.V.
Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-01
Zhenjiang Assure Medical Equipment Co., Ltd.
CAPRI
ORO Co., Ltd.
Spirobank Oxi
Mir Medical International Research USA
Jplant
Jj Medical Co., Ltd.
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Vivachek Biotech (Hangzhou) Co., Ltd.
ZEPTO Precision Capsulotomy System
Centricity Vision, Inc.
FMS VUE Fluid Management and Tissue Debridement System
DePuy Mitek, Inc.
PerfusionGo Plus
Yukun (Beijing) Technology Co., Ltd.
Promogran Prisma Collagen Matrix with ORC and Silver
Solventum Germany GmbH
MeVis Liver Suite
MeVis Medical Solutions AG
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Healgen Scientific,, LLC
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
PainFreeze II
Nuance Medical, LLC
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
Fujifilm Corporation
SPARK Scan
Spark Neuro, Inc.
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