11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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