12 results · 36ms · 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.

STRAP EASE 400

FDA 510(k)
FDA Class 2 ·Physical Medicine

SYRINGE 50ML 18G 1-1/2IN SBDM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·April 2, 2018

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS

FDA 510(k)
FDA Class 2 ·Neurology

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

MINICAP TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 9, 2014

SCULPTRA

FDA Adverse Event
Injury ·AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·October 19, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 26, 2007

IBS

FDA Adverse Event
Malfunction ·IN2BONES SAS·Product code HWC·March 20, 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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018