14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOMARK STERILE INDIA INK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Phonak
FDA UDI
Sonova AG·07613275614228·Phonak Naída B50-R RIC (beige)
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981187651·Left Tip, Wide
COLOR-MONOGEN
FDA 510(k)
FDA Class 2
·Immunology
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ULTRA-FINE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 11, 2019
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 5, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
M2A 38MM ONE PIECE CUP SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 5, 2015
M2A 38MM MOD HEAD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·November 5, 2015
VIDAS® CA 15-3 ASSAY
FDA Adverse Event
Injury
·BIOMERIEUX, SA·Product code LTK·March 8, 2018
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 21, 2021
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