17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964016828·The ENDO CARRY-ON Procedure Kit contains all of...
GRADIA®
FDA UDI
Gc America Inc.·D0470019841·GRADIA® DIRECT Unitips: 10 tips 0.16 mLCT
GRADIA®
FDA UDI
Gc America Inc.·14548161073660·GRADIA® DIRECT Unitips: 10 tips 0.16 mLCT
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450173312·
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·July 20, 2025
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 5, 2012
RESTORE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·September 19, 2012
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·March 13, 2013
RHEUMATOID FACTOR
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHR·February 27, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·February 21, 2008
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
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
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012