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510(k) Number K161866 For BioFlo Midline Catheter From NAVILYST MEDICAL, INC.

Date Received: 2016-07-07

Decision Date: 2016-09-08

Contact: ROBIN FULLER

Address:

City: MARLBOROUGH

State: MA

Product Code: FOZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: General Hospital

Advisory Committee Code under which the product was classified: HO

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161124 For EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear From VISION SCIENCE CO.,LTD.

Date Received: 2016-04-21

Decision Date: 2016-08-26

Contact: OH IN-WHAN

Address:

City: GYEONGSANGBUK-DO

State:

Product Code: LPL

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Ophthalmic

Advisory Committee Code under which the product was classified: OP

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K160854 For MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture From Biomet Manafacturing Corp.

Date Received: 2016-03-28

Decision Date: 2016-12-19

Contact: Adam Cargill

Address:

City: Warsaw

State: IN

Product Code: GAT

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K160739 For Cranial COVER From Neos Surgery S.L.

Date Received: 2016-03-17

Decision Date: 2016-06-12

Contact: Eduard Garcia

Address:

City: Cerdanyola del Valles

State:

Product Code: GXR

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Neurology

Advisory Committee Code under which the product was classified: NE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K160076 For XCage Interbody Fusion System From Ouroboros Medical, Inc.

Date Received: 2016-01-14

Decision Date: 2016-10-13

Contact: John To

Address:

City: Fremont

State: CA

Product Code: MAX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K153650 For Microdent Ektos Implant System From IMPLANTS MICRODENT SYSTEM S.L

Date Received: 2015-12-21

Decision Date: 2016-05-20

Contact: JORDI CLAPES DONADEU

Address:

City: SANTA EULALIA DE RONCANA

State:

Product Code: DZE

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Dental

Advisory Committee Code under which the product was classified: DE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K153501 For Bullfrog Micro-Infusion Device From MERCATOR MEDSYSTEMS, INC.

Date Received: 2015-12-07

Decision Date: 2016-04-15

Contact: KIRK P. SEWARD

Address:

City: EMERYVILLE

State: CA

Product Code: KRA

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Cardiovascular

Advisory Committee Code under which the product was classified: CV

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K153296 For MEDINAUT Kyphoplasty System From IMEDICOM Co., Ltd.

Date Received: 2015-11-13

Decision Date: 2016-07-29

Contact: Bonggu Ha

Address:

City: Gunpo-si

State:

Product Code: NDN

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K130677 For APTUS HELI-FX AORTIC SECUREMENT SYSTEM From APTUS ENDOSYSTEMS, INC.

Date Received: 2013-03-13

Decision Date: 2013-04-12

Contact: BURT GOODSON

Address:

City: SUNNYVALE

State: CA

Product Code: OTD

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Cardiovascular

Advisory Committee Code under which the product was classified: CV

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K000630 For MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM From HOPKINS IMAGING SYSTEMS, INC.

Date Received: 2000-02-24

Decision Date: 2000-05-12

Contact: RICHARD HOPKINS

Address:

City: DUARTE

State: CA

Product Code: LLZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Statement

Advisory Committee: Radiology

Advisory Committee Code under which the product was classified: RA

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K161866	NAVILYST MEDICAL, INC.	BioFlo Midline Catheter	General Hospital	2016-07-07	2016-09-08
K161124	VISION SCIENCE CO.,LTD.	EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear	Ophthalmic	2016-04-21	2016-08-26
K160854	Biomet Manafacturing Corp.	MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture	General, Plastic Surgery	2016-03-28	2016-12-19
K160739	Neos Surgery S.L.	Cranial COVER	Neurology	2016-03-17	2016-06-12
K160076	Ouroboros Medical, Inc.	XCage Interbody Fusion System	Orthopedic	2016-01-14	2016-10-13
K153650	IMPLANTS MICRODENT SYSTEM S.L	Microdent Ektos Implant System	Dental	2015-12-21	2016-05-20
K153501	MERCATOR MEDSYSTEMS, INC.	Bullfrog Micro-Infusion Device	Cardiovascular	2015-12-07	2016-04-15
K153296	IMEDICOM Co., Ltd.	MEDINAUT Kyphoplasty System	Orthopedic	2015-11-13	2016-07-29
K130677	APTUS ENDOSYSTEMS, INC.	APTUS HELI-FX AORTIC SECUREMENT SYSTEM	Cardiovascular	2013-03-13	2013-04-12
K000630	HOPKINS IMAGING SYSTEMS, INC.	MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM	Radiology	2000-02-24	2000-05-12

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