16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Luna 4 plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SpheRx
FDA UDI
Nuvasive, Inc.·00887517442758·SpheRx® II Hook, 6mm Pedicle Small
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022668·FPS 2.7mm 6 Hole Straight Compression Plate
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160045·Integra® Miltex® Glover Coarctation Clamp 8-1-2...
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·04026704597444·COMFORT FLO® Nasal Cannula
n/a
FDA UDI
Ortho Development Corporation·00822409068135·Slotted Stem Trial 24x110mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076906·FPS 2.7 6 Hole Straight Compression Plate Steri...
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
FDA 510(k)
FDA Class 2
·Immunology
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
FDA 510(k)
FDA Class 2
·General Hospital
NOVATION CONSTRAINED LINER LOCKING RING
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWB·November 21, 2008
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
UNIVERSAL OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·July 18, 2013
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
FDA Recall
Open, Classified
·Enterix, Inc.·Product code KHE·September 17, 2025
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
FDA Enforcement
Class II
·Ongoing·Enterix, Inc.·December 10, 2025
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014