14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FILAO NC RX PTCA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Equator
FDA UDI
Preat Corporation·00842092157121·Equator Abutment for BioHorizons 3.0 x 7mm
MODIFICATION TO:EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSELECTRON PDR
FDA 510(k)
FDA Class 2
·Radiology
BMT GB KNEE STM 12X40
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
VIDAS TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 25, 2020
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·August 19, 2021
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024