17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Plato 17 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Syntec-Taichung Bone Plates and Screws
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719875418938·Limited Contact Compression Plate(Narrow)3.5 x ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021470·FPS 3.5mm x 60mm Locking Screw
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105534·GLOBAL RETRACTOR STRAIGHT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075985·FPS 3.5 x 60mm Locking Screw Sterile Qty 2
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
FDA 510(k)
FDA Class 2
·Neurology
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 4, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 25, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
CPS TRANSVERSE PIN 6PK 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 3, 2025
CPS NUT CO-CR-MO ALLOY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 3, 2025
CPS ANCHOR PLUG 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 3, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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