53 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

ADJUSTABLE DRILL GUIDE, BLACK MAX

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

7.2cm Adjustable Drill Guide Product Usage: Electric system

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

FDA Enforcement
Class II ·Terminated·Flower Orthopedics Corporation·October 13, 2021

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·January 20, 2021

Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

FDA Enforcement
Class II ·Terminated·Pdg Product Design Group Inc·October 1, 2014

Sterile Nail Clipper Concave Edge (67710)

FDA Enforcement
Class II ·Terminated·Centurion Medical Products Corporation·June 12, 2019

TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

FDA Enforcement
Class II ·Terminated·Vision RT Ltd·August 31, 2016

Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020

Biograph mCT Flow Edge-4R, Model Number 10528955

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 23, 2018

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 20, 2019

SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 31, 2016

C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

FDA Enforcement
Class II ·Terminated·Atrium Medical Corporation·August 21, 2013

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 12, 2014

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·August 18, 2021

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

FDA Enforcement
Class II ·Terminated·Ethicon, Inc.·February 10, 2021

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 11, 2019