21 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECSYS HCG+B CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040075982·Carbide Bur FG Clinic 330
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120102371·Steel - Excavating burs
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07898663495751·H37-TRAY(30) F/INST.STANDER---BEIGE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450216149·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033116081·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033116074·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033116067·
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
FDA 510(k)
FDA Class 2
·Cardiovascular
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
HENRY SCHEIN INC
FDA Adverse Event
Malfunction
·PRIMA DENTAL GROUP·Product code EJL·June 19, 2025
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 6, 2022
G7 HI-WALL E1 LINER 32MM C
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·February 22, 2023
DISTAL FEMUR LISS INSERTION GUIDE-LEFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·March 19, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 11, 2011
BRAUN
FDA Adverse Event
Malfunction
·BRAUN·Product code JEQ·March 7, 2008
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014