19 results
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21ms
·
Sources: EU EUDAMED, US FDA
TDX(R) BARBITURATES II ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Precept
FDA UDI
Nuvasive, Inc.·00887517387554·PRECEPT Screw Shank, 6.5x50mm Modular
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994291219·SCREW 7896550 CDH PEEK 6.5X50 NON CANN
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916497292·Long-arm Multi-Axial Fenestrated Screw, Ø6.5 x ...
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BEST COLON CLAMP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
QUALA DENTAL PRODUCTS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011
ACE
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 19, 2014
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·November 20, 2012
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CONFIDENCE KIT, NO NEEDLES
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code NDN·January 12, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015