17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII
ArgenZ ST 95x14 ML A1B
FDA UDI
ARGEN CORPORATION, THE·D818130217·Dental porcelain/ceramic restoration kit
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158210646·FORCEPS GERALD DRESSING DELICATE 6.9"
ELMED
FDA UDI
ELMED INCORPORATED·00842180174139·FORCEPS DRESSING, GERALD, 17,5CM, SERRATED
N/A
FDA UDI
Tyber Medical, LLC·M695M1302170·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180593·Integra® Jarit® Tissue Forceps, 6-1/4", 4 x 5 T...
LITE-MED LM-9200 ELMA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
FDA 510(k)
FDA Class 2
·Cardiovascular
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 10, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 1, 2024
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·May 24, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
Artis zee multi-purpose, Model Number 10094139
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025