49 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PUMA System
FDA 510(k)
FDA Class 2
·Orthopedic
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·00855113008159·ClearFit OTS Hemi Left
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293944·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015161·Steinmann Pins, Single diamond, threaded, 3/32-...
NA
FDA UDI
KEY SURGICAL, INC.·10849771050015·Steinmann Pins, Single diamond, threaded, 3/32-...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·February 22, 2022
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 22, 2011
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·September 24, 2008
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 7, 2021
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·September 28, 2023
ULTRATHANE AMPLATZ URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·September 11, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 22, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 16, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·May 5, 2022
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 31, 2022
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 29, 2024