FDA.reportPublic FDA data

La Ada de Acuna

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96160963003807323La Ada de Acuna1N2026-01-01KM 4.5 CARRETERRA PRESA LA AMISTAD CIUDAD DE ACUNA Coahuila MX 26220

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2191081636309761K981393MICROCOOL SURGICAL GOWNFYA1998-07-10
2191081348970114K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALMSH1997-12-22
2191081933271860K973827KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKCT1998-02-11
2191081848356869K932834TECNOL PCM 2000FXX1994-05-03
2191081336919336K905865ANTI-FOR SURGICAL FACE MASKFXX1991-03-06
2191081160318085K905749SURGICAL FACE MASKFXX1991-03-04
2191081445205446K902546THE PROTECTOR & HIGH PERFORMANCE SPLASH MASKFXX1990-09-05
2191081624914805K881471KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAPFRG1988-08-10
2191081217984180K880386KIMBERLY-CLARK PROTECTIVE SLEEVEFYA1988-06-23
2191081960623381K880382KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWNFYA1988-06-23
2191081961736208K874608TECNOL FLUID SHIELD SURGICAL MASKFXX1987-12-02
2191081830703812K873785TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPEFXX1987-11-02
2191082004848570K864116ANAGO ISOLATION MASK (#80-950)LGM1986-11-25
2191081941168376K862801SPUNGUARD PLUS SURGICAL DRAPEKKX1986-08-07
2191081203890433K861600SPUNGUARD PLUS SURGICAL GOWNFYA1986-05-12
2191081737399599K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
2191081054222930K840229CONTROL COVER GOWNFYC1984-03-19
2191081661859457K832194SURGICAL FACE MASK-DISPOSABLEFXX1983-07-26
2191081127139069K831148HIGH FILTRATION ISO-MASKFXX1984-07-17
2191081855716555K823078SPUNGUARD FACE MASKFXX1983-01-07
2191081011237400K781682SURGICAL GOWNS & DRAPESFYA1978-12-20
2191081001206858K780169MASK, SURGICALFXX1978-02-13
2191081697352478K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapFRG2026-05-18
2191081814134431K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX2025-12-11
2191082064913162K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorFXX2026-03-18
2191081066308593K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free ProceFXX2025-05-30
2191081189448379K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapFRG2024-09-16
2191081931162626K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallMSH2024-01-12
2191081702927418K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)FXX2024-07-02
2191081462713333K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX2024-06-04
2191081642068807K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)FXX2024-06-14
2191081438255923K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)FXX2024-06-21
2191081150882429K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)FXX2024-06-07
2191081710407125K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)FXX2024-07-01
2191081174002766K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical GownFYA2021-07-21
2191081423230951K200522AERO CHROME* Breathable Performance Surgical GownsFYA2020-03-16
2191081535258628K192362Aero Blue Performance Surgical GownsFYA2019-12-13
2191082073414486K192147Halyard ONE-STEP* Sterilization WrapFRG2019-10-10
2191081203908075K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)FRG2019-03-22
2191081712265835K162930Aero Chrome* Select Breathable Performance Surgical GownsFYA2017-04-21
2191081966177727K153255Aero Chrome* Breathable Performance Surgical GownFYA2016-04-13
2191081256039332K143287Fluidshield* Surgical Mask with Expanded ChamberFXX2015-03-24
2191081844265388K143053KIMGUARD ONE-STEP Sterilization WrapFRG2015-04-03
2191081461498367K142782KIMGUARD ONE-STEP Sterilization WrapFRG2015-03-09
2191081339350061K141712KIMGUARD ONE STEP STERILIZATION WRAPFRG2014-12-18
2191081319800453K141612KIMGUARD ONE-STEP STERILIZATION WRAPFRG2014-08-07
2191081834483766K141071KIMGUARD ONE-STEP STERILIZATION WRAPFRG2014-07-28
2191082010872622K140963KIMGUARD SMART-FOLD STERILIZATION WRAPFRG2014-11-10
2191081472932996K140539AERO BLUE PERFORMANCE SURGICAL GOWNFYA2014-06-09
2191081475009353K131879KC 300 SURGICAL MASKFXX2013-12-20
2191081582388722K113806KIMGUARD ONE STEP STERILIZATION WRAPFRG2013-08-20
2191081896605472K113340KIMBERLY-CLARK CHILD'S FACEMASKOXZ2012-05-04
2191081160770842K112805KIMGUARD ONE-STEP STERILIZATION WRAPFRG2012-06-22
2191081050592838K112300KIMGUARD SMART-FOLD* STERILIZATION WRAPFRG2012-01-19
2191081795748406K111402KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODELFXX2011-10-20
2191081353283267K110455KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKSFXX2011-04-29
2191081182871611K103150KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASKOXZ2011-09-23
2191081756203101K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
2191081991870168K093115KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100FYA2010-03-19
2191081970486710K092167KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600FRG2009-11-02
2191081403086332K091685KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600FRG2009-09-03
2191081516744545K091357MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400FYA2009-08-10
2191081227844033K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
2191081020787473K082554KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600FRG2009-05-01
2191081861480440K082177KIMGUARD ONE-STEP STERILIZATION WRAPFRG2009-03-27
2191081099674064K080795ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWNFYA2008-09-03
2191081656867289K052824KIMBERLY-CLARK PROCEDURE GOWNFYA2006-05-02
2191081447777061K033021KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADSDWJ2003-11-12
2191081622310009K002577ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADSDWJ2000-10-26
2191081038501935
2191081110360189
2191081453643037
2191081712751822
2191081777759070
2191081064457172
2191081292572580
2191081311588033
2191081469140942
2191081634217859
2191081648265556
2191081662622203
2191081686504963
2191081825615515
2191081895520246
2191081972675591

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FXX272026-03-18
FRG212026-05-18
FYA152021-07-21
KKX42010-11-09
MSH32024-01-12
OXZ32012-05-04
DWJ22003-11-12
KCT11998-02-11
LGM11986-11-25
FYC11984-03-19