Atlas FDA

FYA

297 FDA 510(k) clearances · Product code

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SURGICAL GOWN (EO STERILIZED) (K112796)Cobes Industries Co., Ltd.2013-09-12
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED (K121998)Changzhou Holymed Products Co., Ltd.2012-12-20
SURGICAL GOWN, SMS (K121152)Jiangsu Guangda Medical Material, Co., Ltd.2012-12-12
DISPOSABLE SURGICAL GOWNS (K120192)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2012-10-16
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV (K120045)Exact Medical Manufacturing, Inc.2012-06-12
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER (K111535)Exact Medical Manufacturing, Inc.2011-08-26
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE (K111067)Kunshan Jiehong Nonwoven Product Co., Ltd.2011-08-02
SURGICAL PROCEDURE PACKS (K110724)Omnia Spa2011-06-23
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE (K101468)3M Company Corp2011-04-14
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO (K102692)Hangzhou Jincheng Medical Supplier Manufacture Co.2011-03-11
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (K102971)Microtek Medical, Inc.2011-02-23
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN (K093835)Bam Corp., Ltd.2011-02-04
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS (K102652)Gri Medical & Electronic Technology Co., Ltd.2011-02-03
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS (K103406)Kimberly-Clark Corp.2010-12-23
ATEK SURGICAL GOWNS (K100971)Hangzhou Atek Medical & Textile Co., Ltd.2010-09-27
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL (K101593)Exact Medical Manufacturing, Inc.2010-09-03
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 (K093115)Kimberly-Clark Corp.2010-03-19
LAC-MAC INNERBLOC LR SURGICAL GOWNS (K092344)Lac Mac, Ltd.2009-12-17
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) (K093169)A Plus International, Inc.2009-11-12
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 (K091357)Kimberly-Clark Corp.2009-08-10
SRI LEVEL II SURGICAL GOWN (K090383)Sri Surgical2009-05-29
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 (K091097)Promedical Products Co., Ltd.2009-05-27
SKLAR SURGICAL GOWN (K082479)Sklar Corp.2009-04-24
SRI LP GOWN (K080723)Sri/Surgical Express, Inc.2008-11-13
SRI PLR GOWN (K080707)Sri/Surgical Express2008-11-13
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN (K080795)Kimberly-Clark Corp.2008-09-03
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A (K080627)Promedical Products Co., Ltd.2008-04-24
STRYKER STRI-SHIELD FLYTE TOGAS (K073017)Stryker Instruments, Instruments Div.2007-11-30
WELMED, INC. SURGICAL GOWNS (K070431)Welmed, Inc.2007-05-24
STRYKER T6 HOODS AND TOGAS (K063005)Stryker Instruments2007-03-23
JOYKEY SURGICAL GOWNS (STERILE) (K062479)Joykey Industryial , Ltd.2007-03-14
STRYKER T4 HYTREL TOGA (K070078)Stryker Instruments, Instruments Div.2007-02-02
MICROTEK MEDICAL SURGICAL GOWN/TOGA (K062899)Microtek Medical, Inc.2007-01-25
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS (K062969)Medline Industries, Inc.2006-12-14
LAC-MAC INNERBLOC O.R. GOWN (K061491)Lac Mac, Ltd.2006-08-09
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N (K061308)Cardinal Health 200, Inc.2006-06-05
KIMBERLY-CLARK PROCEDURE GOWN (K052824)Kimberly-Clark Corp.2006-05-02
COMPE1 1 -PLY SURGICAL GOWNS (K060181)Standard Textile Co., Inc.2006-03-07
IMC SURGICAL GOWNS (K052550)Intl. Medsurg Connection, Inc.2005-11-17
CARLO SURGICAL GOWN (K051426)Sofilm Technology Co., Ltd.2005-08-02
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (K041653)Standard Textile Co., Inc.2005-07-01
BARRIER SURGICAL GOWNS (K050786)Molnlycke Health Care2005-05-09
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (K041540)Standard Textile Co., Inc.2005-05-05
COMPEL SURGICAL GOWNS (K041539)Standard Textile Co., Inc.2005-04-28
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 (K043004)Viasys Medsystems2005-03-16
COMPEL MLR SURGICAL GOWNS (K041541)Standard Textile Co., Inc.2005-03-16
MEDLINE SURGICAL GOWNS (K043585)Medline Industries, Inc.2005-03-08
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS (K043017)Medline Industries, Inc.2005-03-08
PROMEDICAL SURGICAL GOWNS (K042111)Promedical Products Co., Ltd.2004-12-10
MAXAIR SURGICAL HELMET SYSTEM (K040485)Bio-Medical Devices, Inc.2004-10-18
STRYKER T4 HYTREL ZIPPER TOGA (K040764)Stryker Corp.2004-04-27
INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) (K032631)Lac Mac, Ltd.2004-02-05
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (K033057)Deroyal2003-11-20
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (K031408)Deroyal2003-10-15
MEDLINE REUSABLE SURGICAL GOWNS (100X) (K031933)Medline Industries, Inc.2003-09-16
LAC-MAC LIMITED INNERBLOC O.R. GOWN (K030536)Lac Mac, Ltd.2003-05-06
DEROYAL GOWNS, STERILE, NON-STERILE (K030364)Deroyal Industries, Inc.2003-04-28
DHS DISPOSABLE HOOD SYSTEM (K021992)Biomet, Inc.2003-01-14
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN (K023635)Sri/Surgical Express, Inc.2002-11-18
PRIMAGARD SURGICAL GOWNS (K023266)Primeline Medical Products, Inc.2002-11-08
BREATHABLE SURGICAL GOWN (K023167)Allegiance Healthcare Corp.2002-10-02
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA (K022162)Stryker Instruments2002-08-01
ULTRAGARD IMPERVIOUS REINFORCED GOWN (K013846)Precept Medical Products, Inc.2002-05-22
CONVERTORS SMS POLYOLEFIN GOWN (K020593)Allegiance Healthcare Corp.2002-03-18
MASTER & FRANK SURGICAL GOWNS (STERILE) (K012186)Master & Frank Ent. Co., Ltd.2001-12-07
TRIMAX (K012268)Standard Textile Co., Inc.2001-12-03
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE (K012240)Mercan AB2001-10-15
BREATHABLE IMPERVIOUS GOWNS (K012984)Allegiance Healthcare Corp.2001-09-24
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (K010799)Standard Textile Co., Inc.2001-06-07
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES (K003755)Medline Industries, Inc.2001-02-16
STACKHOUSE LENS HOOD, MODEL SA-700/FS (K003194)Stackhouse, Inc.2000-10-26
STACKHOUSE LENS HOOD, MODEL SA-700/F (K000605)Stackhouse, Inc.2000-08-17
KLINIDRAPE REINFORCED SURGICAL GOWNS (K000902)Molnlycke Health Care, Inc.2000-07-11
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION (K000901)Molnlycke Health Care, Inc.2000-07-05
MODIFICATION TO CONVERTORS SURGICAL GOWNS (K001189)Allegiance Healthcare Corp.2000-04-21
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS (K993170)Medline Industries, Inc.2000-03-02
CONVERTORS SURGICAL GOWNS, STERILE (K994244)Allegiance Healthcare Corp.2000-02-18
MED-GUARD SURGEON'S GOWN (K992445)Kappler USA2000-02-18
GOWN BACK, MODEL 13-403N; 13-404N; 13-405N (K992436)Techstyles2000-01-20
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE (K994053)Stryker Instruments1999-12-20
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA (K993148)Stryker Instruments1999-10-15
CONVERTORS SURGICAL GOWNS (K992951)Allegiance Healthcare Corp.1999-09-22
CONVERTORS BREATHABLE SURGICAL GOWNS (K992514)Allegiance Healthcare Corp.1999-08-12
CONVERTORS SURGICAL GOWNS (K991034)Allegiance Healthcare Corp.1999-04-16
BARRIER SURGICAL GOWNS (K990395)Johnson & Johnson Medical, Div. of Ethicon, Inc.1999-04-13
STERILE BACK SURGICAL GOWN WITH HAND TOWEL (K984422)Medical Sterilization, Inc.1999-04-02
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN (K982058)Encompass Group, LLC1999-01-14
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES (K982694)Medline Industries, Inc.1998-12-14
ROTECNO 2000 SURGICAL GOWN (K982059)Encompass Group, LLC1998-11-30
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS (K982693)Medline Industries, Inc.1998-10-28
MICROCOOL SURGICAL GOWN (K981393)Kimberly-Clark Corp.1998-07-10
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK (K981073)Medcom Laundry Service, Inc.1998-05-15
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (K971920)Customed, Inc.1997-12-04
PROVISION SURGICAL HELMET SYSTEM (K972832)Depuy, Inc.1997-10-21
ULTRASOUND TRANSDUCER DRAPE (K970893)Protek Medical Products, Inc.1997-10-20
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN (K962666)Bemiss-Jason Corp., Triad Medical Div.1997-02-27
P1OP2B OR P1O92T (K954674)Kay Borch A/S1997-01-30
COOL-ZONE (K963809)Kappler USA1996-11-20
CONVERTORS POLYOLEFIN FABRIC GOWNS (K961341)Baxter Healthcare Corp1996-10-28
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL (K961239)Depuy, Inc.1996-09-17
← Previous Next →

Track FYA automatically

Every clearance here is in the API, with alerts when new ones post.