11 results · 30ms · Sources: EU EUDAMED, US FDA

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INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

REPROCESSED DYONICS ARTHROSCOPIC BURS

FDA 510(k)
FDA Class 2 ·Orthopedic

SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII

FDA 510(k)
FDA Class 2 ·Orthopedic

TPRLC 133 T1 PPS HO 15X150MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 29, 2019

G7 HI-WALL ARCOMXL LNR 36MM G

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·March 29, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·April 17, 2013

NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A

FDA Adverse Event
Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·April 11, 2011

DEXTRUS 4135

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·June 10, 2008

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