18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BESMED JET NEBULIZER BOTTLE SET
FDA 510(k)
FDA Class 2
·Anesthesiology
NEB100
FDA Adverse Event
Malfunction
·SUNSET HEALTHCARE SOLUTIONS·Product code CAF·January 29, 2019
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218259·
CONMED
FDA UDI
Conmed Corporation·10845854029305·MICRO TAPERED FISSURE BUR, MEDIUM, 1.6 X 3.8 MM...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450310496·
XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SIB CATHETER, MODEL 61-7005
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
UNKNOWN HEXLOC CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 3, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 17, 2011
BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿G
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTN·March 15, 2023
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 13, 2022
PROXIMAL HUMERUS, RIGHT, 11X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 13, 2022
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 13, 2022
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 13, 2022
BLUNT TIP SCREW, 4X60MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 13, 2022
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