21 results
·
20ms
·
Sources: EU EUDAMED, US FDA
FRESENIUS 2008T HEMODIALYSIS MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MR-BI320-PA 3T
FDA UDI
Noras MRI products GmbH·04251269207006·The intended use of MR-BI320-PA 3T is, in conju...
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491794·LOCKING SCREW, CROSS-PIN
LEONE SPA
FDA UDI
LEONE SPA·08033707009429·CALIBRA 1ST MOLAR BANDS n.UR 5
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369468282·
Radius Loop Electrodes
FDA UDI
GYNEX CORPORATION·GYNX1205051·
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017909·Wide Jaw Punch large 3.5mm 15 degree down
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197034586·Standard operating scissors
14,5 c...
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
HTO PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
MODULAR HEAD COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·July 12, 2024
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
ARCOS MODULAR REVISION HIP SYSTEM 13X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 2024
ACTIVE ARTICULATION E1 HIP BRG 22X36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 3, 2024
G7 DUAL MOBILITY ACETABULAR LINER 36MM B
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 3, 2024
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 30.0 mm; Ref 96-0517.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005