16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
PALACOS®
FDA UDI
Heraeus Medical GmbH·04260102136151·The PALACOS® R pro system consists of a mixing ...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370847·STRETCHER PAD 30" W X 3.5" H X 74" L SOFTCARE PLUS
RADIUS COUGAR WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
FDA 510(k)
FDA Class 2
·General Hospital
HAHN TAPERED IMPLANT 4.3 X 13MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 13, 2023
LINEAR? 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 6, 2026
FEMUR CEMENTED (CR) NARROW LEFT SIZE 7
FDA Adverse Event
Injury
·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code MBH·May 29, 2024
ALL POLY PATELLA CEMENTED 32 MM DIAMETER
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code MBH·May 29, 2024
ARTICULAR SURFACE (MC) LEFT 18 MM HEIGHT
FDA Adverse Event
Injury
·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code MBH·May 29, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 26, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)·Product code LZG·July 22, 2008
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Recall
Open, Classified
·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012