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