13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WANDY SELF-ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
CONGRUENT BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013
AUTOPULSE LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 29, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·October 1, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 17, 2011
AVENIR CMPL HA VAR NC SIZE 5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 22, 2024
ZB 12/14 COCR HD 36MM X +3.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 22, 2024
G7 VIT E HIGH WALL LNR 36MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 22, 2024
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023