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Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

FDA Enforcement
Class II ·Ongoing·Voco GmbH·February 28, 2024

IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement

FDA Enforcement
Class II ·Ongoing·Voco GmbH·February 28, 2024

Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

FDA Enforcement
Class II ·Ongoing·Peter Lazic Gmbh·March 20, 2024

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

FDA Enforcement
Class II ·Ongoing·Peter Lazic Gmbh·March 20, 2024

D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.

FDA Enforcement
Class II ·Ongoing·Peter Lazic Gmbh·March 20, 2024

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

FDA Enforcement
Class II ·Terminated·Abbott Gmbh & Co. KG·May 16, 2018

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013