12 results
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22ms
·
Sources: EU EUDAMED, US FDA
EyeBOX EBX-4.1
FDA 510(k)
FDA Class 2
·Neurology
MedDrain
FDA UDI
ARMM INC.·10850082007278·MedDrain 11mm Mediastinal Catheter 6 Eyes - Top
LCP
FDA UDI
Synthes GmbH·10886982168047·4.5MM LCP® PROXIMAL FEMUR PLATE 16 HOLES/391MM-...
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295122869·TOTAL KNEE REV REAMER 16mm
LLD EZ
FDA 510(k)
FDA Class 2
·Cardiovascular
STERRAD NX STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
10MM/125 DEG TI CANN TFNA 170MM - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·May 2, 2018
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014