9 results · 25ms · Sources: EU EUDAMED, US FDA

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ISG VIEWING WAND

FDA 510(k)
FDA Class 2 ·Neurology

P.F.C. SIGMA

FDA UDI
DEPUY (IRELAND)·10603295233732·P.F.C. SIGMA FLUTED FEMORAL STEM 20mm x 175mm 5...

HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

ENDO-LOK L-40 ENDOCARDIAL PACING ELECT.

FDA 510(k)
FDA Class 3 ·Cardiovascular

PENTA

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 25, 2013

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 14, 2011

ESPIRIT

FDA Adverse Event
Death ·PHILIPS RESPIRONICS·Product code CBK·July 23, 2014

Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

FDA Enforcement
Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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