19 results
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29ms
·
Sources: EU EUDAMED, US FDA
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
FDA 510(k)
FDA Class 2
·Immunology
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...
NA
FDA UDI
STRYKER CORPORATION·04546540893598·8.0mm Caspar Blade
MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTISTIM
FDA 510(k)
FDA Class 2
·Anesthesiology
TACTICATH
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code OAE·January 31, 2018
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 2, 2013
ETRAK PLUS
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·March 16, 2011
HARMONY SLIDER
FDA Adverse Event
Malfunction
·ABBOTT SPINE, INC.·Product code GAD·April 18, 2008
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016