14 results
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19ms
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Sources: EU EUDAMED, US FDA
Solero Microwave Tissue Ablation (MTA) System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
Med Spec Boxer Splint
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235810·
LCP
FDA UDI
Synthes GmbH·10886982157959·3.5MM LCP PLATE 8 HOLES 111MM
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
FDA 510(k)
FDA Class 2
·Cardiovascular
COMFORT AGILE SCOOTER, LY-EW303
FDA 510(k)
FDA Class 2
·Physical Medicine
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 15, 2023
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·August 5, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 25, 2011
ENDURANCE BONE CEMENT 80G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·July 12, 2013
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·September 20, 2023
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