16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTEGRA LAMINOPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925016866·WILLIAMS MICROCLIP INSERTER
MTAPE 1.5"X10 YARD
FDA UDI
Mueller Sports Medicine, Inc.·00074676138305·MTAPE 1.5" X 10YD TEAMPAK PINK
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
B. BRAUN NERVE BLOCK CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 4, 2025
MAGNUM M2A RECAP CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 24, 2026
MAGNUM M2A
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 24, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 24, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014
DA+ C SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
Core Biopsy Tray Catalog Number: 8673R4
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018