17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BracePaste
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746150821·ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE CARP...
BracePaste
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746059322·ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE CARP...
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476088·
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KPS-I, THE KIDNEY PERFUSION SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
B9220, 84" BI-FUSE BLOOD SET
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·June 30, 2004
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 25, 2011
NEXGEN COMPLETE KNEE SOLUTIONS STEMMED TIBIAL COMPONENT PRECOAT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSH·April 18, 2008
BLUNT TIP SCREW, ÿ 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·April 21, 2025
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 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
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