FDA.report

Tim Karlovsky

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30028075233002807523Tim Karlovsky1N2026-01-011101 Corporate Dr. McHenry IL US 60050

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
108021353634960K984589PHOTOTHERAPY LAMPLBI1999-04-20
108022037533423K962612BILIBED PHOTOTHERAPY LAMPLBI1996-12-12
108021236941366K923577BREAST SHELLSHFS1993-01-22
108021968316324K901344MEDELA BATTERY OPERATED BREAST PUMPHGX1990-08-06
108021815885526K875300MEDELA BREAST-PUMP LACTINAHGX1988-04-06
108021308229883K853176CANNON BABYSAFE NIPPLE SHIELDSHFS1985-08-22
108021599693522K841492AB VACUUM EXTRACTOR SILC-CUPHDB1984-05-07
108021742695724K834129MEDELA APGAR TIMERLHB1984-01-10
108021179183623K830012MEDELA SUCTION PUMPHDB1983-01-24
108021360025244K801862MEDELA ELECTRIC BREAST PUMPHGX1980-10-23
108021352440068K251377Magic InBraHGX2025-09-18
108021900875268K223388Invia® Integrated DressingOMP2023-07-07
108021595446582K210759Solo, Swing MaxiHGX2021-08-11
108021334293008K191653Freestyle FlexHGX2019-10-17
108021998623624K182191Invia Abdominal Dressing KitOMP2019-02-01
108021793144193K180415Invia White Foam NPWTOMP2018-11-02
108021486260506K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPadOMP2018-05-09
108021469909521K170329Basic, Dominant FlexQPB2017-03-24
108021038254198K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent FilmOMP2017-04-06
108021940600121K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyOMP2016-12-01
108021169697834K153663Vario 8/18/ciBTA2016-05-18
108021858262235K151632Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ RentalHGX2015-11-05
108021109185443K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyHGX2015-04-21
108021904397365K150134Basic, Dominant Flex, KV-6QPB2015-04-21
108021779157189K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty CanistersOMP2015-06-12
108021230139905K141553MEDELA THOPAZ+BTA2014-08-25
108021141009005K130210MEDELA THOPAZBTA2013-03-15
108021297729997K130123BASIC AND DOMINANT FLEX SUCTION PUMPSBTA2013-10-11
108021775220499K113678INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2012-10-01
108021918372712K080357MEDELA INVIA WOUND THERAPYOMP2008-07-24
108021918495581K080212MEDELA THOPAZ, MODEL 200 0288BTA2008-07-23
108021218781440K063336MEDELA DOMINANT 50 LIPO, MODEL 600-5706QPB2007-02-26
108021087951042K061435MEDELA VARIO SUCTION PUMPSOMP2006-06-08
108021113614271K061205MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATORBTA2006-06-21
108021028760283K053052MEDELA SWING BREAST PUMPHGX2006-05-02
108021880330610K043544MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATORBTA2005-01-07
108021394214581K041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791HDB2005-04-21
108021757139641K033179MEDELA CLARIO HOME CARE PUMPBTA2003-10-15
108021570064794K021368MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057BTA2002-05-15
108021437177616K020518MEDELA SYMPHONY BREAST PUMP, MODEL 024HGX2002-03-07
108021160520066
108021473364849
108021474542902
108021620947603

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HGX112025-09-18
OMP102023-07-07
BTA92016-05-18
QPB32017-03-24
HDB32005-04-21
LBI21999-04-20
HFS21993-01-22
LHB11984-01-10