12 results · 21ms · Sources: EU EUDAMED, US FDA

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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