18 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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STIMULUS - DISSECTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Natus
FDA UDI
XLTEK·00382830016377·Natus Quantum Pin Box 193-256
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568316·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568347·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568309·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568293·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568330·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033568323·
Brisbane Trial Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215044336·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197411172·Standard Operating Scissors Fig. 3
straig...
ERO SCAN OAE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 13, 2008
ECHELON ENDOPATH
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 30, 2017
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