24 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK 2 YEAST CASPOFUNGIN
FDA 510(k)
FDA Class 2
·Microbiology
MEDLINE INDUSTRIES, INC.
FDA UDI
MEDLINE INDUSTRIES, INC.·10198459467462·BIOPSY TRAY
Preci 52
FDA UDI
Preat Corporation·00842092109328·Preci 52 Standard Female Only
Oticon
FDA UDI
Oticon A/S·05707131189783·K130, ITC P DIR R BE
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
FDA 510(k)
FDA Class 2
·Radiology
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 1, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
XTRA AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code CAC·August 2, 2021
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021