14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRONEB ULTRA MODEL NUMBER 85B0100
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450269060·
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SAMSUNG 10DR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 31, 2026
KIT,LAP CHOLE (CGWG )186
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code LRO·March 27, 2013
EV1000 CLINICAL PLATFORM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·March 13, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·February 16, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
NCOMPASS NITINOL TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·March 28, 2018
NCOMPASS NITINOL TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·May 9, 2018
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024