17 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WIENER LAB. BILIRRUBINA TOTAL AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRESSURE WIRE SENSOR, MODEL 12003/12303
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PRECISIONGLIDE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·September 7, 2021
BD PRECISIONGLIDE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 23, 2021
BD HYPODERMIC NEEDLE PRECISIONGLIDE¿
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 28, 2021
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·December 15, 2023
TRANSWARMER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code IMD·March 21, 2013
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·February 24, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 2008
UNSPECIFIED BD NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 9, 2021
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·December 15, 2023
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