89 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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MILAGRO ADVANCE PEEK Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169639607·SHAFT 2161001 OLIF25 INTERBODY THREADED
ENDOLIGHT
FDA UDI
Richard Wolf GmbH·04055207012932·LIGHT SOURCE LED 1.2 76W LED, low operating no...
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000878634·SHAFT 2161001 OLIF25 INTERBODY THREADED
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004497·Logic Jr. Distractor, Right 52mm
RHEAD
FDA UDI
Stryker GmbH·00886385005102·Sharp Hook
Eargo SE
FDA UDI
Eargo, Inc.·00850010429571·Eargo SE Replacement Charger
STERILE STORM (R) OPERATING KIT
FDA 510(k)
FDA Class 2
·Orthopedic
THERMASSAGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·July 23, 2014
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 17, 2011
PIVOX OBLIQUE LATERAL SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·June 24, 2021
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
T2¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·April 7, 2026
VERTESTACK CORNERSTONE PSR
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·April 7, 2026
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
PIVOX OBLIQUE LATERAL SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·November 1, 2020
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·June 15, 2023
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·August 2, 2023