510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
3,400 total clearances
No Stress Impress
No Stress Impress, LLC
Power Wheelchair (JJW-6001)
ZheJiang J&J Mobility Co., Ltd.
PAL Sterilization Case
Microaire Surgical Instruments, LLC
AffloVest® Mobile Airway Clearance Therapy
Tactile Medical
IPL Hair Removal Device, model: AI01
Shenzhen Century Dongyuan Technology CO , Ltd.
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
Nxstage Medical, Inc.
Plum Duo Infusion System
Icu Medical, Inc.
F65 Laser System
Lumenis Be, Ltd.
FITBONE® Transport and Lengthening System
Orthofix Srl
iGPS Navigation Instruments
SI-BONE, Inc.
Polyver Silver Alginate Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Guangzhou Xinbo Electronic Co., Ltd.
SMB Luer lock disposable syringe
Smb Corporation of India
Acetaminophen
Sekisui Diagnostics P.E.I., Inc.
PRO-LITE Sterilization Tray
STERIS Corporation
Fecobionics Anorectal System
Gi Bionics, LLC
Myocardial Strain Software Application
Circle Cardiovascular Imaging
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T
Shenzhen RF Tech Co., Ltd.
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd
Varios Combi Pro2
Nakanishi, Inc.
OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology, Inc.
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
Liofilchem s.r.l.
PLEXR PLUS
Gmv S.R.L.
Anatase Spine Surgery Navigation System
Remex Medical Corp.
Total Flow Medical Femoral Arterial (TFA) cannula
Total Flow Medical Limited
Suture Button Repair System
Skeletal Dynamics, Inc.
Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves
Avecena Gloves Sdn Bhd
IsoSphere
Isoaid, LLC
Spo2 Sensor CSS032D
Shenzhen Ykd Technology Co., Ltd.
Venus Nova (FP-2001)
Venus Concept, Inc.
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