14 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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AMSURE FOLEY INSERTION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANATOMIC PEEK PTC Cervical Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169357549·CAGE 5030664 ANATOMIC PTC 16X14X6MM
Atmos
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746150951·SUPPLIES ATMOS THERMOFORMING MATERIAL .035 125m...
DMI
FDA UDI
D-M-S HOLDINGS, INC.·00041298006640·WHEELCHAIR 18 FLIP UP DESK ARM
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 1, 2025
DELFIA NEONATAL IRT KIT, MODEL A005-110
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·March 27, 2013
SHILEY LOW PRESSURE CUFFED
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code JOH·March 18, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 15, 2008
K-WIRE Ø1.25 THREAD-TIP L150/5 SST
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code LRN·September 29, 2017
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024