29 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 23, 2022
Diowave Laser System, REF: Diowave 250W
FDA Enforcement
Class II
·Ongoing·Technological Medical Advancements LLC·May 20, 2026
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 13, 2019
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·May 21, 2025
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
FDA Enforcement
Class II
·Ongoing·REPLIGEN CORPORATION·January 21, 2026
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
FDA Enforcement
Class II
·Ongoing·Covidien LP·February 7, 2024
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·November 19, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·August 20, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·February 5, 2025
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·October 17, 2018
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024