13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
FDA 510(k)
FDA Class 2
·Radiology
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HARDYDISK CEFUROXIME, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 4, 2024
SIEMENS 1.5T TXRX 15 CH KNEE
FDA Adverse Event
Other
·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·May 9, 2022
ENDOPATH STEALTH CIR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·May 10, 2011
DEEP DISH
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·April 29, 2013
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·July 21, 2008
BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 10, 2023
BD PEGASUS SAFETY CLOSED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 19, 2023
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