12 results
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28ms
·
Sources: EU EUDAMED, US FDA
WINCO MODEL POWER SERIES LIFT CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902936326·SCREWDRIVER 8080533 TSRH RP DS SHAFT
Clamp, Hysterectomy, model Z 30.5cm angled
FDA UDI
Geister Medizintechnik GmbH·04057034373231·Clamp, Hysterectomy, model Z
30.5cm...
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VOCOM IMPLANT- 8MM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TENDRIL STS
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·April 26, 2013
ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·April 22, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015