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

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SILHOUETTE FC

FDA 510(k)
FDA Class 2 ·Radiology

Proteus XR/a (SlOK : K993090)

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code KPR·August 9, 2019

Proteus XR/a (SlOK : K993090)

FDA Enforcement
Class II ·Ongoing·GE Healthcare, LLC·October 2, 2019

Walgreens

FDA UDI
WALGREEN CO.·00311917194028·Full Adhesive Heat Wraps Neck, Shoulder & Wrist...

artegral life

FDA UDI
Merz Dental GmbH·D7091993090·anteriors; shade A3; mould UBM

HCG Zirconia Ceramic Block

FDA 510(k)
FDA Class 2 ·Dental

GALILEOS IMPLANT, VERSION 1.7

FDA 510(k)
FDA Class 2 ·Radiology

SUPRAMID BLACK 5/0 (1) 45CM DS16

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·January 17, 2019

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 7, 2013

COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 16, 2011

MYOCARDIAL LEAD

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

SUPRAMID WHITE 2/0 (3) 100M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·November 4, 2019

SUPRAMID BLACK 4/0 (1.5) 45CM HS15

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·July 31, 2019

DAFILON BLUE 2/0 (3) 75CM DS24 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·July 1, 2019

DAFILON BLUE 4/0 (1.5) 45CM DS16 (M)

FDA Adverse Event
Injury ·B.BRAUN SURGICAL SA·Product code GAR·October 15, 2019

DAFILON BLUE 2/0 (3) 75CM DS30

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·October 4, 2019

VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders

FDA Enforcement
Class II ·Terminated·Ortho-Clinical Diagnostics·October 26, 2016

SUPRAMID BLACK 2/0 (3) 5X45CM

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAR·August 20, 2020

SUPRAMID BLACK 4/0 (1.5) 45CM DS16

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·May 15, 2019

FLEXOCRIN 6/0 (0.7) 60CM DS9

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·June 5, 2019