FDA 510(k) Applications for Medical Device:
Wrap, Sterilization
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013003 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K103210 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K141693 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K093649 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K062510 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K040865 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K093493 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K053389 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K041623 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K160755 | AHLSTROM NONWOVENS LLC |
2 ELM STREET | WINDSOR LOCKS | CT | 06096 |
| K171533 | Ahlstrom Nonwovens LLC |
2 Elm Street | Windsor Locks | CT | 06096 |
| K983299 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K983719 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K993871 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K012931 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K990300 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K143117 | AMERICAN ORTHODONTICS |
3524 WASHINGTON AVENUE | SHEBOYGAN | WI | 53081 |
| K971483 | AMERICAN THRESHOLD INDUSTRIES, INC. |
240 SARDIS RD. | ENKA | NC | 28728 |
| K152291 | ANDERSEN STERILIZERS, INC. |
3154 CAROLINE DRIVE | HAW RIVER | NC | 27258 |
| K200335 | Andersen Sterilizers, Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K170429 | Andersen Sterilizers, Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K200336 | Andersen Sterilizers, Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K170437 | Andersen Sterilizers,Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K152058 | Andersen Sterilizers,Inc. |
3154 Caroline Drive | Haw River | NC | 27258 |
| K110954 | ARJO WIGGINS MEDICAL, INC. |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K062100 | ARJO WIGGINS MEDICAL, INC. |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K042580 | BANTA HEALTHCARE GROUP, LTD. |
2454 MCMULLEN BOOTH RD. | CLEARWATER | FL | 33759 |
| K172280 | BH Medical Products Co., Ltd. |
No.90 Shenjiang Villagers Group, | Changzhou | 213024 | |
| K983223 | BRASSELER USA I, L.P. |
1679 KELLOGG SPRINGS DR. | ATLANTA | GA | 30338 |
| K181174 | Cardinal Health 200 LLC |
3651 Birchwood Drive | Waukegan | IL | 60085 |
| K151445 | CARDINAL HEALTH 200, LLC |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K151788 | Cardinal Health 200, LLC |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K161910 | CARDINAL HEALTH 200, LLC |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K112211 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAAN ROAD | WAUKEGAN | IL | 60085 |
| K112283 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAAN ROAD | WAUKEGAN | IL | 60085 |
| K112918 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAAN ROAD | WAUKEGAN | IL | 60085 |
| K120658 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K123857 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K130927 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K122507 | CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K120542 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
1430 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K123289 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
1430 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K132060 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
1430 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K213907 | Care Essentials Pty Ltd |
103 Mornington Street | North Geelong | 3215 | |
| K972138 | CARR METAL PRODUCTS, INC. |
3735 NORTH ARLINGTON AVE. | INDIANAPOLIS | IN | 46218 |
| K023658 | CARR METAL PRODUCTS, INC. |
6329 WEST WATERVIEW COURT | MCCORDSVILLE | IN | 46055-9501 |
| K112904 | CASE MEDICAL, INC. |
19 Empire Blvd | S Hackensack | NJ | 07606 |
| K080558 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K022978 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K161415 | CASE MEDICAL, INC. |
19 EMPIRE BLVD. | SOUTH HACKENSACK | NJ | 07606 |
| K030853 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K991023 | CASE MEDICAL, INC. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K023614 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K974638 | CASE MEDICAL, INC. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K090068 | CASE MEDICAL, INC. |
65 RAILROAD AVE. | RIDGEFIELD | NJ | 07657-0402 |
| K993255 | COLTENE/WHALEDENT INC. |
750 CORPORATE DR. | MAHWAH | NJ | 07430-2009 |
| K993835 | COLTENE/WHALEDENT INC. |
750 CORPORATE DR. | MAHWAH | NJ | 07430-2009 |
| K052992 | CONMED LINVATEC |
11311 CONCEPT BOULEVARD | LARGO | FL | 33773-4908 |
| K955678 | CONTOUR FABRICATORS OF FLORIDA, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K955688 | CONTOUR FABRICATORS OF FLORIDA, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K955686 | CONTOUR FABRICATORS OF FLORIDA, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K110867 | CPAC, INC. |
2364 LEICESTER RD. | LEICESTER | NY | 14481-0175 |
| K960208 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960206 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960207 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960210 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960238 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960213 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960211 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960201 | GE MEDICAL SYSTEMS |
1247 FLORDIA AVE. | PALM HARBOR | FL | 34683 |
| K960202 | GE MEDICAL SYSTEMS |
1247 FLORDIA AVE. | PALM HARBOR | FL | 34683 |
| K960204 | GE MEDICAL SYSTEMS |
1247 FLORDIA AVE. | PALM HARBOR | FL | 34683 |
| K960141 | GE MEDICAL SYSTEMS |
1247 FLORDIA AVE. | PALM HARBOR | FL | 34683 |
| K990567 | GLOBAL HEALTHCARE, INC. |
130 BRANTLEY RD. | ATLANTA | GA | 30350 |
| K052665 | GRANTON MEDICAL LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K023025 | GRANTON MEDICAL LTD. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K141412 | GS MEDICAL PACKAGING, INC. |
1400 MARSHALL ST. NE | MINNEAPOLIS | MN | 55413 |
| K141712 | Halyard Health |
1400 MARSHALL ST. NE | MINNEAPOLIS | MN | 55413 |
| K102783 | HINSON AND HALE MEDICAL TECHNOLOGIES, INC |
7809 ADELAIDE DRIVE | AUSTIN | TX | 78739 |
| K961227 | J.J. SKINNER, INC. |
STARKS BUILDING, SUITE 825 | LOUISVILLE | KY | 40202 |
| K182656 | Jiangsu Zhande Medical Supplies Co., Ltd |
Nanjing Binjiang Economic Development Park | Nanjing | 211178 | |
| K222151 | Kenpax International Limited |
Flat 5, 5/F, Wing On Plaza, | Hong Kong | á999077 | |
| K112805 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K082177 | KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE | DAWSONVILLE | GA | 30534 |
| K091685 | KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE | DAWSONVILLE | GA | 30534 |
| K092167 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K140963 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K112300 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076-2199 |
| K082554 | KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE | DAWSONVILLE | GA | 30534 |
| K113806 | KIMBERLY-CLARK HEALTH CARE |
33 TECHNOLOGY DRIVE | Irvine | CA | 92618 |
| K141071 | KIMBERLY-CLARK HEALTH CARE |
1400 HOLCOMB BRIDGE ROAD | ROSWELL | GA | 30076 |
| K141612 | KIMBERLY-CLARK HEALTH CARE |
1400 HOLCOMB BRIDGE ROAD | ROSWELL | GA | 30076 |
| K142782 | Kimberly-Clark Health Care |
1400 Holcomb Bridge Road | Roswell | GA | 30076 |
| K143053 | KIMBERLY-CLARK HEALTH CARE |
1400 HOLCOMB BRIDGE ROAD | ROSWELL | GA | 30076 |
| K102864 | LAC MAC, LTD. |
7809 ADELAIDE DR. | AUSTIN | TX | 78739 |
| K964256 | MADISON POLYMERIC ENGINEERING |
495 WARD ST. EXTENSION | WALLINGFORD | CT | 06492 |
| K182184 | MDK (ShangHai) Medical Packing Co., Ltd. |
No. 233 Fengijan Rd, FengCheng Town, FengXian District | ShangHai | 201409 | |
| K970152 | MEDCARE MEDICAL GROUP, INC. |
234 OLD HOMESTEAD HWY. | EAST SWANZEY | NH | 03446 |
| K960520 | MEDCO INSTRUMENTS, INC. |
C/O BURDITT & RADZIUS | CHICAGO | IL | 60606 |
| K010825 | MEDLINE |
ONE MEDLINE PLACE | MUNDLELEIN | IL | 60060 |
| K152458 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K143147 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDLELEIN | IL | 60060 |
| K150698 | MEDLINE INDUSTRIES, INC. |
1 MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K152564 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K162993 | Medline Industries, Inc. |
One Medline Place | Mundelein | IL | 60060 |
| K113353 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K192641 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K002968 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K220365 | Medline Industries, LP |
Three Lakes Drive | Northfield | IL | 60093 |
| K192147 | Owens & Minor (O&M) Halyard, Inc |
9120 Lockwood Blvd | Mechanicsville | VA | 23116 |
| K214007 | Owens & Minor (O&M) Halyard, Inc. |
9120 Lockwood Blvd | Mechanicsville | VA | 23116 |
| K181959 | Owens& Minor Halyard, Inc. |
5405 Windward Parkway | Alpharetta | GA | 30004 |
| K212198 | Plasmapp Co,.Ltd. |
BVC-111, 125, Gwahak-ro, Yuseong-gu | Daejeon | 34141 | |
| K223025 | Plasmapp Co., Ltd. |
BVC-111, 125, Gwahak-ro, Yuseong-gu | Daejeon | 34141 | |
| K160595 | PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI |
Karaduvar Mah Serbest Bolge, 11 cad, No. 46, | Mersin | 33020 | |
| K162362 | PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS |
KARADUVAR MAH.SERBEST BOLGE, 11.CAD NO.46 | MERSIN | 33020 | |
| K152669 | PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD |
MERSIN TARSUS ORGANIZE SANAYI BOLGESI 12, CAD NO.2 HUZURKENT | MERSIN | 33020 | |
| K221875 | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
Dongjing Road 23, Yuanlin Office | Qianjiang | 433100 | |
| K013715 | QUALITY PRODUCTS OF MONTANA |
100 NORTH JOHNSON #7 | MISSOULA | MT | 59801 |
| K993535 | RILEY MEDICAL, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K031022 | RONPAK, INC. |
4301 NEW BRUNSWICK AVE. | SOUTH PLAINFIELD | NJ | 07080 |
| K153540 | SAFE SECURE PACKAGING CO., LTD |
NO.4 CHENGGUANG INDUSTRIAL PARK | SHENZHEN | 518100 | |
| K112591 | SAFE SECURE PACKAGING CO., LTD |
CHENGGUANG INDUSTRIAL PARK, | SHENZHEN, GUANGDON | 5181100 | |
| K180139 | Safe Secure Packing Co., Ltd. |
Yaoshan Industrial Park | Dongguan City | 523601 | |
| K071886 | SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. |
1558-1-2101 SOUTH XIZANG ROAD | SHANGHAI | 200011 | |
| K102158 | SIGMA MEDICAL SUPPLIES CORP. |
# 15-2, LN 26, MINEYUAN 1ST RD | KAOHSIUNG | 802 | |
| K180661 | Sigma Medical Supplies Corp. |
NO.34, Ding-Ping Road, Rui Fang Industrial Park | New Taipei City | 224 | |
| K133838 | SIGMA MEDICAL SUPPLIES CORP. |
15F-2, LN 26, MINEYUAN 1ST RD | KAOHSIUNG CITY | 802 | |
| K202462 | Sigma Medical Supplies Corporation |
NO.34, Ding-Ping Road, Rui Fang Industrial Park, | New Taipei City | 224 | |
| K180672 | Sigma Medical Supplies Corporation |
NO.34, Ding-Ping Road, Rui Fang Industrial Park, | New Taipei City | 224 | |
| K191131 | Solidence Surgical Corporation |
1104 San Fernando Road | San Fernando | CA | 91340 |
| K162162 | Standard Textile Co., Inc. |
One Knollcrest Drive | Cincinnati | OH | 45237 |
| K172207 | Standard Textile Co., Inc. |
One Knollcrest Drive | Cincinnati | OH | 45237 |
| K212338 | SterileRight Packaging Mfg., Inc. |
1F, No.33-7, Dahua 2nd Rd., Qidu Dist. | Keelung City | 206 | |
| K222440 | Steris |
5960 Heisey Road | Mentor | OH | 44060 |
| K071087 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K160908 | STERIS CORPORATION |
5960 HEISLEY RD | MENTOR | OH | 44060 |
| K183297 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K183401 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K140487 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K172749 | Steris Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K231500 | Steris Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K962605 | SURGICOT, INC. |
4018 PATRIOT DR., | RESEARCH TRIANGLE PARK | NC | 27709 |
| K113776 | SYMMETRY MEDICAL |
61 JOHN VERTENTE BLVD | NEW BEDFORD | MA | 02745 |
| K141826 | SYMMETRY MEDICAL INC- MANCHESTER |
253 ABBY ROAD | MANCHESTER | NH | 03103 |
| K181957 | Tianchang Jiarui Packaging Material Co., Ltd. |
Yeshan Industria Zone | TianChang | 239300 | |
| K162258 | Tianchang Jiarui Packaging Material Co., Ltd. |
Yeshan Industria Zone | TianChang | 239300 | |
| K955658 | TRANSIDYNE GENERAL CORP. |
400 HERALD JOURNAL PARK | SPARTANBURG | SC | 29303 |
| K080198 | TSO3 INC. |
33 BLACK WATCH TRAIL | FAIRPORT | NY | 14450 |
| K200240 | Turbett Surgical Inc. |
125 Tech Park Drive | Rochester | NY | 14625 |
| K202593 | Turbett Surgical Inc. |
125 Tech Park Drive | Rochester | NY | 14625 |
| K153025 | TURBETT SURGICAL LLC |
125 TECH PARK DRIVE SUITE 2108 | ROCHESTER | NY | 14623 |
| K990761 | TUTTNAUER USA CO. LTD. |
1333 NEW HAMPSHIRE AVE., N.W. | WASHINGTON | DC | 20036 |
| K123162 | U&U MEDICAL TECHNOLOGY CO., LTD |
DONGZHOU VILLAGE, HENGSHANQIAO | CHANGZHOU | 213119 | |
| K143637 | U&U Medical Technology Co.,Ltd |
Dongzhou Village, Hengshanqiao | Changzhou,Jiangshu | 213119 | |
| K040707 | VYGON US LLC |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
| K041096 | WAGNER GMBH |
22411 60TH STREET | BRISTOL | WI | 53104 |
| K220133 | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
No.567, Gushan Road, Area of Economy and Technique | Weihai | 264207 | |
| K193561 | Weihai Xingtai Packaging Products Co.,Ltd. |
Sunjiatan Industrial Zone, Yangting Town, Huancui area | Weihai | 264200 | |
| K183356 | Weihai Xingtai Packaging Products Co.,Ltd. |
Sunjiatan Industrial Zone, Yangting Town, Huancui area | Weihai | 264200 | |
| K062704 | WINNER INDUSTRIES (SHENZHEN) CO., LTD. |
1O37 WALNUT AVE. | POMONA | CA | 91766 |
| K210810 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K221377 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K221379 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K221016 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K231996 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K231999 | Wipak OY |
Wipaktie 2 | Nastola | FI-15560 | |
| K223600 | Wuhan Zonsen Medical Products Co., Ltd. |
No 8 Jinchao Rd, Zhucheng Street | Wuhan |
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