19 results
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28ms
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Sources: EU EUDAMED, US FDA
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610501·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .02...
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 50mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020984·
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044204636·TEST TUBE 13X100MM 2-POS CAP
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
CALCIJECT
FDA 510(k)
FDA Class 2
·Dental
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 8, 2015
LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 9, 2015
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2008
KAZ SMARTHEAT
FDA Adverse Event
Other
·KAZ INC·Product code IRT·April 4, 2011
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 9, 2024
TI OSS RS AXLE YOKE KIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 5, 2018
OSS AVL YOKE SET WITH BUSHINGS AND CLIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 9, 2018
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022