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
Bifix Veneer LC, Bifix Veneer Try-In
Voco GmbH
Monkey Bars Pin to Bar External Fixation System
Paragon 28, Inc.
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40
Surgical Instrument Service and Savings, Inc.
CHENA-C Spacer System
Kahtnu Surgical, Inc.
Arthrex SutureTak Suture Anchor
Arthrex, Inc.
Glass Ceramics
Yilink (Tianjin) Biotechnology Co., Ltd.
XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
Transit Scientific, LLC
Bullsai
Turing Medical Technologies, Inc.
SignalNED System (Model RE)
Forest Devices, Inc.
BD Epilor Syringe
Becton, Dickinson and Company
14F iSLEEVE Introducer Set
Boston Scientific Corporation
Legend® Acetabular Shell
Ortho Development Corp.
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
Orthofix Srl
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Rapid Biomedical GmbH
High speed air turbine handpiece
Foshan Topmed Dental Co., Ltd.
C-Stem AMT LE Prosthesis
Depuy Ireland UC
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
Shenzhen Huachuangtong Industrial Co., Ltd.
MIST IC
Imagine Milling Technologies, LLC
Ti Link Abutment
Izenimplant Co., Ltd.
OTTAVA Robotic Surgical System
Auris Health, Inc., part of Johnson & Johnson MedTech
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
GE Healthcare Finland Oy
Sclerotherapy & Endoscopic Needles
G-Flex Europe Sprl
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Smith & Nephew Medical Limited
Sonio Suspect
Sonio
DESS Dental Smart Solutions
Terrats Medical SL
TELIGEN System
Medos International SARL
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
Lumenis Be, Inc.
Saige-Dx (3.1.0)
DeepHealth, Inc.
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 8
Philips Medizin Systeme Böblingen GmbH
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic)
Pegavision Corporation
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