14 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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MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
CONQUEROR MEDICAL (PVT) LTD.
FDA registration
CONQUEROR MEDICAL (PVT) LTD.·11 products·🇵🇰 Pakistan
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 20, 2025
SUPRASPERM SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
8043404-2006-00001
FDA Adverse Event
Other
·Product code HDC·May 8, 2006
PADS - PEDIATRIC
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 11, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 15, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 13 mm; Product 903213225.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 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