17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAUSCH & LOMB IOL INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304007352·
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136025582·3L 5530 GERATHERM SPEC AL ROD
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105384·PS3 Screw 8.5mm x 50mm
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JOBST READY-TO-WEAR GAUNTLET
FDA 510(k)
FDA Class 2
·General Hospital
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2013
PLMA DVC V11.51 1 R
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 17, 2011
COMP LOCKING SCREW 4.75X35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019
VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·August 15, 2018
COMP RVRS SHDR GLEN BSPLT +HA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019
COMP LOCKING SCREW 4.75X35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019
COMP LOCKING SCREW 4.75X20MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 15, 2019
COMP LOCKING SCREW 4.75X15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·August 15, 2018
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025