373 results
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 19, 2020
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 19, 2020
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Enforcement
Class II
·Terminated·Northern Digital Inc.·July 22, 2015
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Enforcement
Class II
·Terminated·Northern Digital Inc.·July 22, 2015
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·December 4, 2019
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
FDA Enforcement
Class II
·Ongoing·Palodex Group Oy·August 21, 2024
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Enforcement
Class II
·Ongoing·TELEFLEX MEDICAL INC·March 31, 2021
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Ltd.·December 16, 2020
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·October 7, 2020