19 results · 27ms · Sources: EU EUDAMED, US FDA

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BD SINGLE USE, HYPODERMIC SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

BD LUER SLIP¿ TUBERCULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

ADVIA Centaur® DIG

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177410·Digoxin - CENTAUR - RGT - 50 tests

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803604·Bookwalter Tray for Rings & Posts: 330 x 558 x ...

Vaginal CT/MR Multi Channel Applicator

FDA UDI
Nucletron B.V.·08717213022461·Fixation Screw Set

PERIOLASE ND:YAG DENTAL LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RELINE-IT MODEL RELINE-IT

FDA 510(k)
FDA Class 2 ·Dental

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 1, 2011

BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·September 27, 2021

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

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