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
ICHOR 7F Embolectomy System (ICH-7F)
Ichor
Bluebird Single-Use Respiratory Effort Belt
Cadwell Industries, Inc.
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Institut Straumann AG
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc.
Oxygen Concentrator, Model JAY-5AW
Longfian Scitech Co., Ltd.
Medusa Orthopedics Boa External Fixation System
Medusa Orthopedics, LLC
External Hex Implant System
Southern Implants (Pty), Ltd.
PowerGlide Pro Midline Catheter
Becton, Dickinson and Company (Bard Access Systems, Inc.)
MISHA Knee System
Moximed, Inc.
safety lancet
Tianjin Huahong Technology Co., Ltd.
T2 Biothreat Panel
T2biosystems, Inc.
Xenoview VDP
Polarean, Inc.
Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Stryker GmbH
Instylla Delivery Kit
Instylla, Inc.
PeriCALM Patterns 3.0
Perigen, Inc.
KARL STORZ ICG Imaging System
Karl Storz Endoscopy America
Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance
Ambu A/S
IPL Hair Removal, Model: OBT-02
Glan Electronics Co., Ltd.
IlluminOss Photodynamic Bone Stabilization System
Illuminoss Medical, Inc.
OnyxCeph
Image Instruments GmbH
Emboliner Embolic Protection System (EPC-03)
Emboline, Inc.
First To Know Syphilis Test
Nowdiagnostics
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Cixi Ruihong Electric Appliance Co., Ltd.
IDS ACTH II
Immunodiagnostic Systems Limited
Fundus On Phone Non Mydriatic (FOP NM-10)
Remidio Innovative Solutions Private Limited
Heel Incision Safety Lancet (SteriHeel 2)
SteriLance Medical (Suzhou), Inc.
STRUXXURE® MCS Anterior Cervical Plate System
Nexxt Spine
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEA
Olympus Corporations of the Americas
Vinyl Examination Gloves
Taian Hengchang Medical Technology Co., Ltd.
Stem Extension Line (USTAR II System)
United Orthopedic Corporation
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