10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEPUY CORAIL HIP SYSTEM, REVISION STEM
FDA 510(k)
FDA Class 2
·Orthopedic
OCTAGON Infinity TL WP Abutment H 5.5 mm, cementable
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50937361·TL WP Abutment H 5.5 mm, cementable for OCTAGON...
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
MERCI RETRIEVER, MODELS 90065, 90066
FDA 510(k)
FDA Class 2
·Cardiovascular
MRI LINE MARKER
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·September 16, 2014
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 12, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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