23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DuoHex CH Cannulated Hammertoe System
FDA 510(k)
FDA Class 2
·Orthopedic
LoFric® Hydro-Kit™
FDA UDI
Wellspect AB·07392532148514·Single Use Urinary Catheter LoFric Hydro-Kit Ne...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257156148·TG LATERAL PANEL PRO TACO XS-MD RIGHT
SISTRUNK SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055834·SISTRUNK SCISSORS STRAIGHT BLADES POWER CUT BLACK
OsteoMed
FDA UDI
OSTEOMED LLC·00845694057196·Multi Function Bender, ICON
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046125·LATERAL IMPLANT, WIDE, STANDARD, 8mm X 23mm X 40mm
Zavation
FDA UDI
Zavation LLC·00842166123335·Lateral Offset
VITAL SCIENTIFIC PT WITH CALCIUM
FDA 510(k)
FDA Class 2
·Hematology
EMBO PLUS EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·December 21, 2015
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·December 3, 2015
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 24, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·August 8, 2011
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·July 2, 2013
VANGUARD KNEE SYSTEM PS TIBIAL BEARING E1 ANTIOXIDANT INFUSED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·May 21, 2019
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014