13 results
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18ms
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Sources: EU EUDAMED, US FDA
HEMAFLOUR ZP
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471186589·Bicuspid Bands, Upper, Size 6
Planmeca ProMax 3D Max, Planmeca Maximity
FDA 510(k)
FDA Class 2
·Radiology
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·September 26, 2012
PFC SIGMARP STB TB IN 5 10.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·July 15, 2010
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·September 26, 2023
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 18, 2019
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 18, 2019
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 3, 2018
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014