17 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HABIB 4X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00514201·
AOS TROCHANTERIC NAIL, RIGHT 10mm x 42cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665015072·
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173340·L Con, Side-Loading, L, 8mm, 420mm
SLIDESCAN
FDA 510(k)
FDA Class 2
·Hematology
MM-87 MOTOR-DRIVE MANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIO MODULAR HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·February 19, 2018
BIOMODULAR SHOULDER HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 16, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 10, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·May 19, 2008
BIOMODULAR SHOULDER HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·February 16, 2018
BIOMODULAR SHOULDER PEGGED GLENOID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 16, 2018
UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITHOUT STOPCOCKS AND/OR Y-SITE)
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FPA·September 28, 2022
MOD ARTHRO NL 1CM ELIP CNCTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 8, 2022
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018