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
MAC 7 Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
Huizhou Foryou Medical Devices Co., Ltd.
Lumify Diagnostic Ultrasound System
Philips Ultrasound
Luvis Chair (LC700C)
Dentis Co., Ltd.
Intense Pulsed Light Therapy Device
Sanhe LEFIS Electronics Co., Ltd.
CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd.
Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Guangzhou Sonostar Technologies Co., Ltd.
Venous Return Cannulae
LivaNova USA, Inc.
JADE SCORE PTA Scoring Balloon Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
Bone Solutions, Inc.
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
Shanghai Caremate Medical Device Co., Ltd.
Jazz
Ai Medical AG
Yumizen H550
HORIBA ABX SAS
Anika Tissue Tack Fixation System
Anika Therapeutics, Inc.
LithoVue Elite Digital Flexible Ureteroscope System
Boston Scientific Corporation
Aperio GT 450 DX
Leica Biosystems Imaging, Inc.
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Sri Trang Gloves (Thailand) Public Company Limited
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
Wilson-Cook Medical, Inc.
CYLOX® ST
Signus Medizintechnik GmbH
OC JuggerKnot Soft Anchor
Riverpoint Medical
Delivery Date AI
Ultrasound AI
Surgical Masks
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
AVIEW Lung Nodule CAD
Coreline Soft Co., Ltd.
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
Maduro Medical, Inc.
Sysmex XW-100 Automated Hematology Analyzer
Sysmex America, Inc.
3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M
3M Company
LORRAINE 2.5/3.5mm Distal Humerus System
Bonebridge AG
Grandio disc multicolor
Voco GmbH
PM2+ System and SmartPICC Stylet
Piccolo Medical, Inc.
Plasonic (Plasonic)
Hironic Co., Ltd.
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