13 results · 28ms · Sources: EU EUDAMED, US FDA

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INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO-MODULAR SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304213814·

GLOBAL

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007494·GLOBAL KEELED GLENOID PREMIERON X-LINKED PE 56mm

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS

FDA 510(k)
FDA Class 2 ·Microbiology

PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

BALL FLUTED 10BA30

FDA Adverse Event
Other ·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBE·December 5, 2006

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 15, 2013

ESSURE

FDA Adverse Event
Malfunction ·BAYER PHARMA AG·Product code HHS·September 24, 2014

AMPHIRION DEEP PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·INVATEC INNOVATIVE TECHNOLOGIES, SPA·Product code DQY·May 17, 2011

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

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

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023