12 results · 27ms · Sources: EU EUDAMED, US FDA

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HOT/COLD PACK HOLDERS

FDA 510(k)
FDA Class 1 ·Physical Medicine

CODMAN® HAKIM®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534914·CODMAN® HAKIM® Precision Fixed Pressure Valve, ...

HUMELOCK II CEMENTED SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GRADIA DIRECT

FDA 510(k)
FDA Class 2 ·Dental

DISTAL TARGETING DEVICE R1.5

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 22, 2012

PV-INLINE W/SG [MH]

FDA Adverse Event
Malfunction ·CODMAN & SHURTLEFF·Product code JXG·July 23, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 2, 2014

PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·December 3, 2007

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·October 10, 2012

PV-INLINE W/SG [MH]

FDA Adverse Event
Malfunction ·CODMAN & SHURTLEFF, INC.·Product code JXG·February 25, 2015

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

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024