14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Belimed Steam Sterilizer MST-H TOP 5000
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131339584·SIYA 1, KIT 312 2.4G NFM 90 L C001
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MASIMO LNCS/M-LNCS OXIMETRY SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
TARGETING ARM PROX. LAT. TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·March 11, 2017
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 26, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·September 30, 2008
STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·January 10, 2019
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024