19 results · 23ms · Sources: EU EUDAMED, US FDA

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INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE

FDA 510(k)
FDA Class 2 ·Dental

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101482·Poly Insert MPCS, Size 1L, 18mm

SNORE GUARD ADVANCE

FDA 510(k)
FDA Class 2 ·Dental

ATHENA MULTI-LYTE EBV IGG TEST SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRE·September 14, 2020

U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

TIBIAL BASEPLATE IMPACTOR

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 3, 2013

ON-Q CATHETER

FDA Adverse Event
Malfunction ·I-FLOW CORP.·Product code BSO·May 26, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

ESOPHYX Z

FDA Adverse Event
Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRE·December 1, 2020

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRE·December 16, 2020

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Death ·COOK VANDERGRIFT INC·Product code DRE·July 12, 2019

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Death ·COOK VANDERGRIFT INC·Product code DRE·September 17, 2020

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Death ·COOK VASCULAR INC·Product code DRE·May 9, 2019

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRE·August 13, 2019

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025