18 results · 20ms · Sources: EU EUDAMED, US FDA

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ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16740914600·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674091460060·

LEONE SPA

FDA UDI
LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450845035·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450214589·

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

FDA 510(k)
FDA Class 1 ·Microbiology

WUJIN #3 TIBIAL BONE PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

GAS MODULE II

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013

NATURALYTE

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014

ALARIS PUMP MODULE

FDA Adverse Event
Injury ·CAREFUSION CORPORATION·Product code FRN·May 4, 2011

BLUNT TIP SCREW, 4X34MM

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022

BLUNT TIP SCREW, 4X42MM

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022

BLUNT TIP SCREW, 4X38MM

FDA Adverse Event
Injury ·ZIMMERSWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022

GMK STD CEMENTED FEMUR SIZE 5 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·May 14, 2014

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