19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004059·PowerChem Neoprene Exam Gloves, Extra Large
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112329·LYNX Humeral Locking Plate, Dorso Lat Anatomica...
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERCURE LTD. RESPI-LOW
FDA 510(k)
FDA Class 2
·Neurology
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
FDA 510(k)
FDA Class 3
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 13, 2024
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 2, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 9, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008
ECHELON OVAL
FDA Adverse Event
Malfunction
·HITACHI MEDICAL CORPORATION·Product code LNH·November 13, 2014
OASIS
FDA Adverse Event
Injury
·HITACHI LTD, HEALTHCARE BUSINESS UNIT·Product code LNH·December 28, 2017
ECHELON OVAL
FDA Adverse Event
Malfunction
·HITACHI MEDICAL CORPORATION·Product code LNH·September 26, 2014
ECHELON OVAL
FDA Adverse Event
Malfunction
·HITACHI MEDICAL CORPORATION·Product code LNH·May 4, 2015
Genesis Uni Articular Inserts
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HSX·June 21, 2004
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