17 results · 34ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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