14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROBEAT
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533133·Vascular Gemini Forceps
Ø5mm, ...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981174170·L Con, Side-Loading, L, 16mm, 280mm
VARIANT II TOTAL GHB
FDA 510(k)
FDA Class 2
·Hematology
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
JGRKNT 1.0MM MINI 3-0 NDLS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·April 28, 2020
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code MLV·March 20, 2020
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 11, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 13, 2011
ATOMIC ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·SPINAL ELEMENTS, INC.·Product code KWQ·May 28, 2008
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
FDA Enforcement
Class II
·Ongoing·Bruder Healthcare Company, LLC·April 3, 2024
M2A-MAGNUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 2018
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 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