16 results · 22ms · Sources: EU EUDAMED, 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