132 results · 27ms · Sources: EU EUDAMED, US FDA

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CARESIDE CREATININE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DeltaForm HD

FDA UDI
Merz Dental GmbH·D7091980043·DeltaForm HD lower posteriors, L, A4 -MADE IN G...

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756047982·ST BIAS STOCKINETTE

ESIS MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

VIZILITE EYEWEAR

FDA 510(k)
FDA Class 2 ·Dental

ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014

LAMITRODE TRIPOLE 16

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 24, 2011

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II and Hancock Ultra II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis, Models T505, T510

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis