15 results
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30ms
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Sources: EU EUDAMED, US FDA
FG-36UX FIBER ULTRASOUND GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854004883·ULTRAPOWER BUR, ROUND COARSE DIAMOND (MUSTARD) ...
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
MEDICAL IMAGE MERGE (MIM)
FDA 510(k)
FDA Class 2
·Radiology
TEMP 3
FDA 510(k)
FDA Class 2
·General Hospital
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·May 11, 2021
QC Ø1-4 F/TRS
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·March 26, 2013
SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHR·March 17, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·March 25, 2008
ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-3
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSD·November 10, 2021
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·July 19, 2021
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018