Smith Nephew

FDA Filings

This page includes the latest FDA filings for Smith Nephew. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Smith Nephew holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Anny Zhao

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K203566 Smith & Nephew	Tablet Application	2021-05-13
PMN K201198 Smith & Nephew	S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable	2020-07-17
PMN K192876 Smith & Nephew	INTELLIO Tablet Application	2020-02-27
PMN K190367 Smith & Nephew	Smith & Nephew Tablet Application	2019-05-21
PMN K172785 Smith & Nephew	CONQUEST FN	2017-12-22
PMN K163653 Smith & Nephew	NOVOS-NAIL Limb Lengthening System (LLS)	2017-10-13
PMN K153606 SMITH & NEPHEW	LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS Camera Head, Camera Coupler, Tablet Application	2016-06-02
PMN K152686 Smith & Nephew	CONQUEST FN	2016-03-17
103691 BLA SMITH AND NEPHEW		0000-00-00 00:00:00
101995 BLA SMITH AND NEPHEW		0000-00-00 00:00:00
089434 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
089251 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
089043 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088960 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088767 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088766 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088749 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088581 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088580 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088531 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088530 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088521 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088519 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088518 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088460 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088458 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088429 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
088239 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
087959 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
087958 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
087906 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
087904 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
087592 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
071750 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
071682 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
071681 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
071671 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070841 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070802 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070697 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070696 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070634 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070633 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070623 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070622 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070137 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070135 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070078 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070047 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070046 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070023 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00
070011 ANDA SMITH AND NEPHEW		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

SMITH & NEPHEW, INC.
Smith & Nephew Ltd
Smith & Nephew Orthopaedics Ltd
Smith&Nephew Orthopaedics AG
Smith & Nephew (Suzhou) Limited
SMITH AND NEPHEW MEDICAL LTD.
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS028 Date Received10/25/2022 Decision Date11/18/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS027 Date Received08/31/2022 Decision Date09/29/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS026 Date Received08/23/2022 Decision Date09/21/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS024 Date Received08/05/2022 Decision Date09/01/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS023 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS049 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS048 Date Received06/06/2022 Decision Date07/05/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS022 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS047 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SMITH&NEPHEW ORTHOPAEDICS7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS021 Date Received04/29/2022 Decision Date05/17/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS019 Date Received03/07/2022 Decision Date04/01/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SMITH&NEPHEW ORTHOPAEDICS
Smith & Nephew Wound Management

Related Finance Registrations

NCAGE Code	B2651	SMITH & NEPHEW
CAGE Code	B2651	SMITH & NEPHEW

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200922158	Felixstowe ,United Kingdom -> Savannah, Georgia	BANDAGE	2316 CAS
20200716191	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MOBILE ROLLER CABINET DIMS 110 X 213 X 90 CM HS-CODE 9402900090	1 PKG
20200703215	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MOBILE ROLLER CABINET DIMS 110 X 213 X 90 CM HS-CODE 9402900090	1 PKG
202002085015	Salalah,Oman -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	8 PKG
2020020110279	Salalah,Oman -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	8 PKG
202001235943	Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	18 PKG
2020010427976	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MOBILE ROLLER CABINET DIMS 110 X 213 X 90 CM HS-CODE 9402900090	1 PKG
2019122828316	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MOBILE ROLLER CABINET DIMS 110 X 213 X 90 CM HS-CODE 9402900090	1 PKG