12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLUCOSE TOLERANCE BEVERAGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MLKJ
FDA UDI
Weifang Mingliang Electronics Co., Ltd.·06974077940023·
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ALTON PT STEPPER
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 20, 2025
INZII RETRIEVAL SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL TECHNOLOGY, INC·Product code GCJ·March 27, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
ACUITY STEERABLE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
VNGD SSK 360 FEMUR R 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT SPLINED KNEE STM V2 12X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT 360 TIB 5.0 OFFSET ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
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