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