64 results
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13ms
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Sources: EU EUDAMED, US FDA
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
FDA Enforcement
Class II
·Terminated·Hitachi Medical Systems America Inc·August 29, 2012
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable
FDA Enforcement
Class II
·Terminated·Adler MicroMed, Inc.·June 30, 2021
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
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
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 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 99-0155/20, Stem size S-4, prox. Stem dia. 20 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 99-0143/22, Stem size 05, prox. Stem dia. 22.5 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 99-0143/20, Stem size 04, prox. Stem dia. 20 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 99-0143/18, Stem size 03, prox. Stem dia. 18 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 99-0143/12, Stem size 0, prox. Stem dia. 12 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