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

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GS Medical AnyPlus PEEK Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

N/A

FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003470·Diagnostic EP Catheter, Damato curve, 4 electro...

ELMED

FDA UDI
ELMED INCORPORATED·00842180175655·ELMED REUSABLE BIPOLAR RF- CABLE,10FT., WITH DU...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694016247·2.0mm Plate Holder

ELMED

FDA UDI
ELMED INCORPORATED·00842180103047·BIPOLAR RF CABLE WITH JARIT, ERBE INSTRUMENT PL...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776147013·4mm dual banana plug (unit) Bipolar Cable

iSmile

FDA UDI
Ismile Dental Products, Inc.·00816419021426·VP Micro Brush Applicator Fine Yellow

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET

FDA 510(k)
FDA Class 2 ·General Hospital

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

FDA 510(k)
FDA Class 2 ·General Hospital

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·September 21, 2007

ASKU

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·August 11, 2011

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·October 24, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·August 27, 2019

ENDOPATH*MULTIFEED STAPLER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 16, 2019

HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 26, 2019

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021