20 results · 38ms · Sources: EU EUDAMED, US FDA

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Cold/Hot Compression

FDA 510(k)
FDA Class 2 ·Physical Medicine

ZESPIN SI Joint Fusion System

FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

LCP

FDA UDI
Synthes GmbH·10886982157874·3.5MM LCP PLATE 4 HOLES 59MM

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

SYNGO.CT NEURO PERFUSION

FDA 510(k)
FDA Class 2 ·Radiology

GMK SPHERE CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

SERI SURGICAL SCAFFOLD (US)

FDA Adverse Event
Injury ·ALLERGAN·Product code OXF·October 29, 2014

AMIS BROACH HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JDI·July 28, 2011

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 12, 2013

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

ACCU-CHEK ® SPIRIT

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·February 27, 2013

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

ACCU-CHEK TENDER

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code FPA·December 13, 2013

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026