13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA FLASH CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ORBIT
FDA 510(k)
FDA Class 2
·Anesthesiology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·May 15, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014
TMJ SYSTEM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·October 16, 2020
TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·October 16, 2020
TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·October 16, 2020
TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·October 16, 2020
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 31, 2024
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022