16 results · 22ms · Sources: EU EUDAMED, US FDA

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TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PAP-CAP

FDA 510(k)
FDA Class 2 ·Anesthesiology

BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316

FDA 510(k)
FDA Class 2 ·Dental

BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code NDP·May 7, 2022

BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·August 29, 2022

BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·August 29, 2022

BD PRO SAFETY ARTERIAL CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·August 29, 2022

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 21, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·July 30, 2014

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