STANLEY

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007735241	3007735241	Stanley H. Salot, Jr.	1	N	2026-01-01	26925 Reiling Avenue Monroe OR US 97456
3015170223	3015170223	STANLEY MEDICAL DESIGNS, INCORPORATED	1	N	2026-01-01	7900 Harbor Island Drive Suite 1514 North Bay Village FL US 33141
3017820141	3017820141	STANLEY TSAI	1	N	2026-01-01	3569 E. VERNON AVE Los Angeles CA US 90058
3039592366	3039592366	Stanley H. Salot, Jr.	1	N	2026-01-01	26925 Reiling Ave Monroe OR US 97456
3042129713	3042129713	Stanley Tsai	1	N	2026-01-01	3569 E Vernon Ave Vernon CA US 90058
3005267659	3005267659	Stanley Tsai	1	N	2020-04-25	3569 E. Vernon Ave Vernon CA US 90058
3008421545	3008421545	Stanley Tsai	1	N	2020-04-25	3569 E Vernon Ave Vernon CA US 90058
3009203425	3009203425	Stanley Ammons	1	N	2020-04-25	121 River Street, 12th floor Hoboken NJ US 07030

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850013858057	Flick-Catcher® - Flick-Catcher® Right Basket, Short	(305)-758-0211	info@stanleymedicaldesigns.com
00850013858064	Flick-Catcher® - Flick-Catcher® Left Basket, Tall	(305)-758-0211	info@stanleymedicaldesigns.com
00850013858071	Flick-Catcher® - Flick-Catcher® Right Basket, Tall	(305)-758-0211	info@stanleymedicaldesigns.com
00850013858088	Moby® - Green Moby® Jointed Cutter Package (Contains 1 each of 00850013858001, 00850013858033, 00850013858118)	(305)-758-0211	info@stanleymedicaldesigns.com

stanleymedicaldesigns.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
102232	1617026705	K254256	LUOFUCON® Wound Matrix	QSZ	2026-08-18
102232	1910849591	K252028	LUOFUCON® Antimicrobial Wound Gel	FRO	2026-03-11
102232	1907620525	K250642	LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)	FRO	2025-11-19
102232	1296974055	K242856	LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)	FRO	2024-11-13
102232	1960056094	K240809	LUOFUCON® Silver Collagen Dressing	FRO	2024-12-16
102232	1215841359	K240485	LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)	FRO	2024-10-07
102232	1933729471	K232796	LUOFUCON® Collagen Particles (Collagen Wound Dressing)	KGN	2024-04-25
102232	1275541790	K223360	LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing	FRO	2024-03-27
102232	1589972880	K223359	LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing	FRO	2023-12-21
102232	1952304053	K221110	LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing	FRO	2024-01-04
342718	1425842889	K213598	LUOFUCON Collagen Wound Dressing	KGN	2022-09-20
102232	1425842889	K213598	LUOFUCON Collagen Wound Dressing	KGN	2022-09-20
102232	1589832821	K211123	LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel	FRO	2022-04-22
102232	1680546010	K210718	LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing	FRO	2022-03-23
102232	1076156807	K201016	LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)	FRO	2021-01-28
102232	1729503419	K173196	SUNTOUCH Dental Dressing	OLR	2018-01-24
102232	2066758844	K172554	LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing	FRO	2018-05-01
102232	1825911691	K170077	LUOFUCON Silicone Ag Foam Dressing with Border	FRO	2017-03-30
102232	1818115713	K160022	LUOFUCON Silicone Ag foam dressing	FRO	2016-08-17
102232	1384931393	K140954	LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING	FRO	2015-03-23
102232	1546929668	K132796	SUNTOUCH EYE SPEAR	HOZ	2013-10-30
102232	1750358277	K120181	LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM	FRO	2013-02-14
102232	1177484695	K112800	SUNTOUCH TOPICAL HEMOSTATIC DRESSING	QSY	2012-05-23
102232	1932186863	K101097	CALGAESEAL MODEL: CAS	QSY	2010-09-22
217098	1182877462
129226	1250816091
129226	1345558005
212045	1396094933
217098	1411875538
217098	1691808490
129226	1739280033
102232	1100115988
102232	1118712561
102232	1177668078
302879	1225052464
102232	1234990907
102232	1260025259
102232	1277457196
281791	1324994774
344070	1331559022
102232	1387525105
281791	1402981123
344070	1406753356
102232	1513659897
102232	1549597248
102232	1595601946
102232	1645888786
281791	1716572480
102232	1797651675
102232	1804314826
102232	1818111725
102232	1918577030
344070	1958305313
281791	1999357501

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FRO	16	2026-03-11
KGN	3	2024-04-25
OLR	2	2018-01-24
QSY	2	2012-05-23
QSZ	1	2026-08-18
HOZ	1	2013-10-30

PMN#

MODEL 381 HOME OXYGEN SENTRY
1981-07-16
STANLEY AVIATION CORP.
MODEL 379 WXYGEN CONCENTRATOR
1980-07-14
STANLEY AVIATION CORP.

GUDID#

Flick-Catcher® - Flick-Catcher® Basket Pair, Tall (Contains 1 each of 00850013858064 and 00850013858071)
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Basket Pair, Short (Contains 1 each of 00850013858040 and 00850013858057)
Stanley Medical Designs, Incorporated
2022-03-01
SoBe® - Blue SoBe® Jointed Cutter Package (Contains 1 each of 00850013858026, 00850013858033, 00850013858118)
Stanley Medical Designs, Incorporated
2022-03-01
SoBe® - Red SoBe® Jointed Cutter Package (Contains 1 each of 00850013858019, 00850013858033, 00850013858118)
Stanley Medical Designs, Incorporated
2022-03-01
Moby® - Green Moby® Jointed Cutter Package (Contains 1 each of 00850013858001, 00850013858033, 00850013858118)
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Right Basket, Tall
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Left Basket, Tall
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Right Basket, Short
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Left Basket, Short
Stanley Medical Designs, Incorporated
2022-03-01
Fast Fish® - Fast Fish® Gauge
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Basket Pair, Tall(Contains 1 each of 00850013858064 and 00850013858071)
Stanley Medical Designs, Incorporated
2022-03-01
Flick-Catcher® - Flick-Catcher® Basket Pair, Short(Contains 1 each of 00850013858040 and 00850013858057)
Stanley Medical Designs, Incorporated
2022-03-01
SoBe® - Blue SoBe® Jointed Cutter Assembly
Stanley Medical Designs, Incorporated
2022-02-25
SoBe® - Red SoBe® Jointed Cutter Assembly
Stanley Medical Designs, Incorporated
2022-02-25
Moby® - Green Moby® Jointed Cutter Assembly
Stanley Medical Designs, Incorporated
2022-02-25
1 YEAR TIMED CHAIR PAD,SIX PACK - 96160
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
1 YEAR TIMED BED PAD,SIX PACK - 96120
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
CHAIR PAD,45DAY,6 PACK,CSM-2W - 95330
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
CHAIR PAD,1YR,6 PACK,CSM-4 - 95260
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
CHAIR PAD,180DAY,6 PACK,CSM-3B - 95250
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
BED PAD,1YR,6 PACK,BSM-4-6 - 95110
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
BED PAD,180DAY,6 PACK,BSM-2B-6 - 95100
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
BED PAD,45DAY,6 PACK,BSM-1W-6 - 95080
STANLEY SECURITY SOLUTIONS, INC.
2021-07-15
KIT, PANEL, PL691, 5-PCS - RP131K
STANLEY SECURITY SOLUTIONS, INC.
2021-07-10
DUMMY PLUG, 1/4" PLASTIC - 5 EA - JK018K
STANLEY SECURITY SOLUTIONS, INC.
2021-07-10