19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109275·HA PEEK EVOS Straight, ,14mmx8mmx 26mm , FLAT 5...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100140·Implant Tray
LOW VOLUME HUMIDIFICATION CHAMBER W/FLOAT &
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code BTT·November 16, 2007
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K1190140·Tray Insert 6, Cosmo MIS,Arcamed
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MIRADRY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LPS 28MM DIAPHYSEAL SLEEVE
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code MBH·May 15, 2013
EON
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
*
FDA Adverse Event
Malfunction
·BIOLITEC, INC.·Product code GEX·June 1, 2011
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·July 15, 2021
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
FDA Enforcement
Class II
·Ongoing·ETAC A/S·February 11, 2026
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021