21 results
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22ms
·
Sources: EU EUDAMED, US FDA
IMPULSE SELECT
FDA 510(k)
FDA Class 2
·Anesthesiology
TruForm
FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·09010782022894·CC/ Opaque Dentine OD-C1
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015791·CC/ Opaque Dentine OD-C1
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001579·artVeneer life upper anteriors, ITM, BL2
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001576·SILICONE FOAM NON BORDER ADHESIVE 10X20CM
TEMPO AQUA ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
FDA 510(k)
FDA Class 2
·Physical Medicine
ZPower Rechargeable System for Hearing Aids
FDA UDI
ZPOWER, LLC·00850034007205·Charger for ZPower Rechargeable System for Hear...
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 13, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 26, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
GOODBABY·Product code INM·August 12, 2014
L3O0200 - NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 28, 2021
VARIABLE ANGLE, SELF TAPPING HEXALOBE SCREW (TI-6AL-4V ELI)
FDA Adverse Event
Injury
·ALPHATEC SPINE INC·Product code KWQ·November 19, 2015
Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016