16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PALACOS R
FDA 510(k)
FDA Class 2
·Orthopedic
Hi-Torque Proceed™
FDA UDI
ABBOTT VASCULAR INC.·08717648321429·Hi-Torque Proceed 170T Angled Guide Wire w/Hydr...
Graves Speculum Medium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030902·Graves Speculum Medium 1 3/8" x 4" (35mm x 102mm)
Optimotion Blue CR HCCR Total Knee System
FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0309020·CR Tibial Insert, UHMWPE + Vitamin E, Size 3, ...
MULTITRACK ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KLINIDRAPE REINFORCED SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPLETE DOUBLE MOIST
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014
TAPERLOC
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·May 2, 2018
PLUM LS PRIM. 225 CM CLAVE PORT DISTA
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013
ROTALINK¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·April 2, 2013
STRATA 2 VALVE, REGULAR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·March 21, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·July 10, 2024
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 14, 2018
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
FDA Enforcement
Class II
·Terminated·GE Healthcare·June 13, 2018
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