16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
FDA 510(k)
FDA Class 2
·Cardiovascular
Malecot
FDA UDI
COOK INCORPORATED·00827002169258·Silicone Malecot Catheter
DISPOSABLE CB-PE MICROKERATOME BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
FINN CHAMBER (R)
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 25, 2022
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·August 21, 2013
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·July 25, 2008
AML 15.0 MMA 6.3 5/8 STD 12/14
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 18, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·June 29, 2012
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 20, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 20, 2012
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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