20 results
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20ms
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Sources: EU EUDAMED, US FDA
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Versacryl
FDA UDI
Keystone Industries·H66810140321·HC Lab Kit, 2-50g Pwd, 1-60 ml Liq. hardener, 1...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555118·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555132·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555125·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555101·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555064·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555088·
Intess L
FDA UDI
Kalitec Direct LLC·B07312K0100320·Assembly, Caddie, 30mm Lumbar Implants, Hinged
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033555095·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0140120·Guide, Anti-Splay
SEED SELECTRON MODEL V. 1.0
FDA 510(k)
FDA Class 2
·Radiology
PERFECTA AND EXTEND
FDA 510(k)
FDA Class 2
·Orthopedic
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
EBI TROCHANTERIC NAIL SYSTEM
FDA Adverse Event
Malfunction
·EBI·Product code JDS·March 14, 2008
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015
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
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