9 results
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18ms
·
Sources: EU EUDAMED, US FDA
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
FDA 510(k)
FDA Class 1
·Radiology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088781·Paddle Distractor, Long, 18mm
PHOSPHOLIN ES AND CALCIUM CHLORIDE
FDA 510(k)
FDA Class 2
·Hematology
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
FDA 510(k)
FDA Unclassified
·Unknown
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·June 24, 2025
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
FDA Adverse Event
Injury
·AV-BARCELONETA·Product code DQX·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
GOBED II NED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 21, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024