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
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Tuttnauer , Ltd.
MONDRIAN Anterior Lumbar Plate System
Ctl Medical Corporation
EDEN Spinal Fixation System
Jmt Co., Ltd.
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
CarboFix Orthopedics , Ltd.
CARA System
Cara Medical, Ltd.
Rotatable Connector (5944RL)
Shenzhen Launch Electrical Co., Ltd.
Qlicksmart BladeFlask UNIVERSAL
Qlicksmart Pty , Ltd.
Micro Ace Advanced Micro Access System
Merit Medical Systems, Inc.
EMM Ultrasonic Transducer Cover
Exact Medical Manufacturing
SimpleStitch Suturing System
Envision Endoscopy
Bloomi Smooth Water Based Lubricant
The Bloomi Inc..
MasterX 800 Series
Medicatech USA
Evolve System with the T3 Applicator
InMode , Ltd.
Bioptimal Bipolar Pacing Catheter
Bioptimal International Pte. , Ltd.
THE Cover
Purgo Biologics, Inc.
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); P
Nanjing Yinuoji Medical Technology Co., Ltd.
Tenex 2nd Generation System
Trice Medical, Inc.
Topwide Surgical Face Mask
Topwide (Hubei) Medical Products Manufacturer
CONTOUR® NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Shenzhen Century Dongyuan Technology CO , Ltd.
VasQ
Laminate Medical Technologies , Ltd.
Led Mask Platinum Md
Cellreturn Co., Ltd.
MONET Anterior Cervical Plate System
Ctl Medical Corporation
Chemfort® Catheter Adaptor
Simplivia Healthcare , Ltd.
QSCHECK UISACR
Qstag, Inc.
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
Osartis GmbH
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
Guangzhou Red Pine Medical Instrument Co., Ltd.
Videa Caries Assist
Videahealth, Inc.
PosiSep X BAM Hemostat Dressing/Intranasal Splint
Hemostasis, LLC
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