18 results · 20ms · 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.

VPAP III ST-A

FDA 510(k)
FDA Class 2 ·Anesthesiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033276·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

RAD-5 PULSE OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

HOURGLASS

FDA Adverse Event
Injury ·MEDTRONIC·Product code MQP·June 16, 2014

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 3, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 18, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

LIFEPAK CR(R) PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021