15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
FDA 510(k)
FDA Class 2
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450554906·
RESOLVE SURGICAL O.R. TOWELS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code DSI·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 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