12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111148675·STEEL RULER 20"
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
PALFIQUE ESTELITE LV
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
ARCOS CON SZ A STD 50MM TRL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·January 10, 2022
IMUFLEX DISPOSABLES
FDA Adverse Event
Malfunction
·TERUMO CORPORATION/TERUMO BCT·Product code CAK·April 17, 2013
PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·June 17, 2008
AU400 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·April 19, 2011
ARCOS 16X150MM SPL TPR DIST
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·January 10, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015