22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
Audit MicroControls Control FD Assayed Chemistry, Level 2
FDA UDI
AALTO SCIENTIFIC·B085K0312100·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197057639·Gross-Maier Swab Forceps
curved...
NEEDLE 23X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·July 23, 2024
NEEDLE 23X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 22, 2024
AUTOMATED CORE BIOPSY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 22, 2024
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011
ACCU-CHEK TENDER INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·April 18, 2008
EVEREST BIPOLAR
FDA Adverse Event
Malfunction
·GYRUS MEDICAL INC.·Product code GEI·August 15, 2006
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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