16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
FDA 510(k)
FDA Class 2
·Cardiovascular
Trumpf Medical
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761979369·Remote control PST 500 D
Control Units PST500
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761973572·Remote control PST 500 D
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049828·Channel Drain, 10mm Flat 3/4 Fluted with 4.7mm ...
M5T INSTANT FEVER THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
FDA 510(k)
FDA Class 1
·General Hospital
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 17, 2022
2.0MM IMF SCREW SELF-DRILLING 12MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code DZL·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 3, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 2, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 7, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
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