18 results · 21ms · Sources: EU EUDAMED, US FDA

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SURETEMP PLUS

FDA 510(k)
FDA Class 2 ·General Hospital

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074195858·PROXIMAL SCREW 5.5 X 80, SS

Tulip Medical Products, Inc.

FDA registration
Tulip Medical Products, Inc.·2 products·🇺🇸 United States

ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15

FDA 510(k)
FDA Class 2 ·Dental

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER

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

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·April 2, 2013

STENOSCOP

FDA Adverse Event
Malfunction ·GE MED SYS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·March 9, 2011

ACCU-CHEK TENDER INFUSION SET

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·April 15, 2008

BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 7, 2018

COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·April 21, 2017

BD SYRINGE WITH NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 29, 2019

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013