22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TREGOR DUAL MOBILITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Premium Plus CEEA
FDA UDI
Covidien LP·10884523006575·Circular Stapler
Relief Pak 4 pack heating Unit
FDA UDI
KARIS Co.,Ltd·08809520550215·It is a device intended for medical purposes th...
Relief Pak 4 pack heating Unit stationary
FDA UDI
KARIS Co.,Ltd·08809520550529·It is a device intended for medical purposes th...
MHS 5000
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·May 14, 2013
DERMABOND TOPICAL SKIN ADHESIVE
FDA Adverse Event
Injury
·ETHICON·Product code MPN·June 2, 2011
8.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·August 12, 2008
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 6, 2025
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
LOGIC FEMORAL PS CEM RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 25, 2022
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 26, 2025
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024