Data / Medical devices / United States / Smith & Nephew, Inc.

Smith & Nephew, Inc.: FDA-registered device maker in Lawrenceville, GA, United States, 26 510(k) clearances

Name: Smith & Nephew, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Smith & Nephew, Inc. is registered with the FDA (registration 3010034780) in Lawrenceville, GA, United States. It lists 19 device types. The FDA files 26 510(k) clearances under its listings, the newest dated August 4, 2016. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Smith & Nephew, Inc.

FDA registration number: 3010034780
Address: 2225 Cedars Rd Ste A, Lawrenceville, GA, United States, 30043
Owner or operator: SMITH & NEPHEW, INC. (9002406)
Roles: Repackager or relabeler
First device listed: June 19, 1992
Registered through: 2026
Brand names listed: ALLEVYN, AQUALERT, BANISH II LIQUID DEODORANT, BlueSky Vista Wound Vacuum System, CONFORMANT 2, CicaNet, CovRSite, DERMIVEX and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Repackager or relabeler	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Liquid	KMF	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Repackager or relabeler	accessdata.fda.gov
Beads, Hydrophilic, For Wound Exudate Absorption	KOZ	1	Repackager or relabeler	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Repackager or relabeler	accessdata.fda.gov
Drape, Adhesive, Aerosol	KGT	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Lavage, Jet	FQH	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Repackager or relabeler	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Repackager or relabeler	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Repackager or relabeler	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 4, 2016	K153209	RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply	OMP	Substantially Equivalent	Smith & Nephew Medical, Ltd.	accessdata.fda.gov
November 22, 2011	K112784	RENASYS AB ABOMINAL DRESSING KIT	FTL	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 1, 2011	K110958	VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH	FQH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 22, 2011	K110647	RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS	OMP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 17, 2010	K100787	RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT	FTL	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 6, 2010	K102001	MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY	OMP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 23, 2010	K092712	SKIN BARRIER FILM	KMF	Substantially Equivalent	Lodestar Products, Inc.	accessdata.fda.gov
February 25, 2009	K083375	RENASYS GO NEGATIVE PRESSURE WOUND THERAPY	OMP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 14, 2008	K082211	RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS	OMP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 9, 2008	K080275	NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM	OMP	Substantially Equivalent	Iasis Medical, Inc.	accessdata.fda.gov
September 5, 2008	K082426	RENASYS EZ	OMP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 3, 2007	K063835	ALLEVYN AG DRESSING	FRO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 5, 2007	K061919	VERSATILE 1 EZCARE WOUND VACUUM SYSTEM	OMP	Substantially Equivalent	Blue Sky Medical Group Incorporated	accessdata.fda.gov
August 10, 2006	K061367	BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500	OMP	Substantially Equivalent	Blue Sky Medical Group Incorporated	accessdata.fda.gov
April 12, 2006	K060782	VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE	FQH	Substantially Equivalent	Smith & Nephew Wound Management	accessdata.fda.gov
November 4, 2005	K052456	MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM	OMP	Substantially Equivalent	Blue Sky Medical Group Incorporated	accessdata.fda.gov
November 1, 2004	K042134	VERSATILE 1 WOUND VACUUM SYSTEM	OMP	Substantially Equivalent	Blue Sky Medical Group Incorporated	accessdata.fda.gov
June 22, 2001	K011612	MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM	FQH	Substantially Equivalent	Hydrocision, Inc.	accessdata.fda.gov
March 31, 2000	K991383	HYDROCISION DEBDRIDEMENT SYSTEM	FQH	Substantially Equivalent	Hydrocision, Inc.	accessdata.fda.gov
July 31, 1998	K981713	CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0	MGP	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 25, 1997	K973228	STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)	KMF	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 4, 1994	K943781	ACRYDERM ADVANCED WOUND DRESSING	KMF	Substantially Equivalent for Some Indications	Acrymed, Inc.	accessdata.fda.gov
May 10, 1994	K941263	COMFEEL PLUS WOUND DRESSING	KMF	Substantially Equivalent	Richard Hamer Assoc., Inc.	accessdata.fda.gov
April 28, 1994	K940414	IODOFLEX PASTE	KMF	Substantially Equivalent for Some Indications	Oclassen Pharmaceuticals, Inc.	accessdata.fda.gov
January 31, 1991	K905069	IODOSORB GEL	KOZ	Substantially Equivalent	Perstorp AB C/O Robert Joel Slomoff	accessdata.fda.gov
December 1, 1986	K863930	VISCOPASTE ZINC PASTE BANDAGE	FRO	Substantially Equivalent for Some Indications	Smith & Nephew, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 4, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.