18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIFESTYLES LIQUID PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033076·Baltic Denture System BDLoad Mm7 PLSEbim6DFm D3...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319701386·Piffard Dermal Curette 5-1/2" (14cm), narrow ha...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319718117·Piffard Dermal Curette 5-1/2" (14cm), narrow ha...
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MITEK CUFFTACK
FDA 510(k)
FDA Class 2
·Orthopedic
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 3, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 25, 2011
MEDISENSE OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 22, 2008
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·June 10, 2026
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024