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
Therapy Mask 3100 NC/SP
Respironics, Inc.
Fine Osteotomy
Bodycad Laboratories, Inc.
Wedge XL Delivery Catheter
MicroVention, Inc.
Avenger Radial Head System
In2bones USA, LLC
Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-X
Covidien, LLC
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
ETHICON, Inc.
Jazz Classic
Jazz Imaging
SpeedCath Compact Male
Coloplast
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
DePuy Synthes
BiliWrap
Gerium Medical, Ltd.
Dental Barrier and Sleeves
Yongqing Huaguan Dental Instruments Factory
Teleport Glide Microcatheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
LuxCreo Flexible Partial Denture Resin
LuxCreo, Inc.
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
Seers Technology Co., Ltd.
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
Electric Wheelchair (YFWB-63)
If Health (Xiamen) Intelligent Technology Co.,Ltd
IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
Foshan Newface Electronic Technology Co., Ltd.
Curian® Shiga Toxin
Meridian Bioscience, Inc.
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
Assure Tech., LLC
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
Shenzhen Yuwei Electronic Technology Co., Ltd.
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Roche Diagnostics
SonoMSK
PAJUNK GmbH Medizintechnologie
Transpara 1.7.2
Screenpoint Medical B.V.
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
Guangzhou Berrcom Medical Device Co., Ltd.
SonoAir Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd.
Claritag Advanced
Dgi Technologies
BracePaste Prime Plus
American Orthodontics
Medifun Lancing Device, Model No. LD-E1
Medifun Corporation
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Tyber Medical Staple Fixation System (various)
Tyber Medical, LLC
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