19 results · 21ms · Sources: EU EUDAMED, US FDA

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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