11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
K-ASSAY LP(A) CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
FDA 510(k)
FDA Class 2
·Radiology
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 5, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
BD INSULIN SYRINGE 3/10 ML/CC 31 G X 6 MM HALF UNIT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 11, 2017
12/14 ARTICUL 40MM M SPEC +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 12, 2011
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·May 6, 2013
D-M 1.6MM BEADED CABLE SET VIT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDQ·September 16, 2014
CHEMOSAFELOCK BAG SPIKE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·April 23, 2025
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