12 results
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21ms
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Sources: EU EUDAMED, US FDA
NOSITE UV INTERIM SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519799·CODMAN® HAKIM® Precision Fixed Pressure Valve w...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780535027·Precision Fixed Pressure Valve In-Line Valve wi...
CODMAN HAKIM SIPHONGUARD
FDA UDI
Cerenovus, Inc.·10886704041818·CODMAN HAKIM Precision Fixed Pressure Valve In-...
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
FDA 510(k)
FDA Class 2
·Radiology
Tens & Ems Device
FDA 510(k)
FDA Class 2
·Neurology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 2, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·December 3, 2007
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
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