11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERI-CATH(TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112255·3M™ Victory Series™ First Molar Bands, 902-383,...
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VASCUCLEAR PRECISION BIPOLAR
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code GEI·June 24, 2014
ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 18, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 8, 2013
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 7, 2023
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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