Rosanna Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Rosanna Lee5N2026-01-011200 Townline Rd Mundelein IL US 60060
96813853001751372Rosanna Lee1N2026-01-011200 Townline Rd MUNDELEIN IL US 60060
30041225983004122598Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30045858563004585856Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30058064383005806438Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30066369623006636962Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30070760793007076079Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30070828973007082897Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30072894083007289408Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30103052753010305275Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30103635403010363540Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30106104543010610454Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30114949173011494917Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30118053153011805315Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30129906313012990631Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30130214743013021474Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30149230863014923086Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151051293015105129Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151731653015173165Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151732123015173212Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30154992423015499242Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30159168303015916830Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30164900193016490019Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30167613723016761372Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30170314843017031484Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2819431969249120K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
1753801548560275K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
2819431548560275K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
1753801009589810K990463MEDLINE EXCEL WHEELCHAIRSIOR1999-03-15
311471155731645K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
1753801306180962K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
2819431449574666K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCT1998-08-11
2819431374172959K970946MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SETLJH1997-06-10
1753801809914216K964358AMSEAL SURGICAL FACE MASKFXX1997-02-14
311471741177181K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
311471537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
1753801537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2259571537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2819431537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
311471337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
1753801337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
2259571337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
2819431337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
311471228839100K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKX1996-11-26
1753801228839100K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKX1996-11-26
1753801767008806K961758CARASYN HYDROGEL WOUND PRODUCTSMGQ1996-07-11
2259571828023355K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORJKA1996-08-30
1753801497574083K953669PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSINGMGQ1995-09-22
1753802031462412K953418ELECTROCAUTERY SHROUDGCJ1995-10-07
2819432031462412K953418ELECTROCAUTERY SHROUDGCJ1995-10-07
2819431470331422K953107ANESTHESIA/RESPIRATORY FACE MASKBSJ1995-08-15
2819431756865024K951802SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KITDXT1995-07-21
2819431699744300K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDDRS1996-03-25
311471500525763K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMJSM1995-03-10
311471844805001K942571HYPER-INFLATION BAGNHK1994-06-10
1753801220081613K940555SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONLZH1995-02-01
1753801835835179K936304ELECTROSURGICAL PENCILGEI1994-06-13
2819431835835179K936304ELECTROSURGICAL PENCILGEI1994-06-13
311471808492981K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
311471408349109K932654ELECTROSURGIAL INSTRUMENTSGEI1994-02-22
2259571408349109K932654ELECTROSURGIAL INSTRUMENTSGEI1994-02-22
311471668467939K925591MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYSTBZR1993-09-16
311471411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
1753801411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
2819431411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
2819431341225522K925167MASS SPECTROMETRY MONITORING LINE CONONECTORSCCK1993-01-22
2819431786112190K922410SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOLDQX1992-07-23
1753801444965331K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATORFYD1992-02-12
2819431444965331K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATORFYD1992-02-12
2819431458429210K912975OPERAND LUBRICATING JELLYKMJ1991-09-27
2819432040362720K912132OPERAND LUBRICATING JELLYFHX1991-08-07
2819431420252931K910944MEDIFILKGN1991-04-02
2819431868136624K910764THE PERCEPTOR(TM) STAND ALONE TRANSDUCERDRS1991-04-22
2819431294978461K903606GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCERLIT1990-09-27
311471856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
1753801856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
2819431856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
2819431009445154K902472MORSE DT MANIFOLDDRS1990-08-23
2819431824137242K900783MDI ADAPTORCAF1990-07-18
2819431020143902K900652NAMIC PTCA Y-ADAPTORDTL1990-06-26
2819431043443632K896108THE PILOT SCIMED TORQUE DEVICELOX1990-01-09
2819431613668369K896087PALESTRANT IRRIGATION AND DRAINAGE SETKGZ1989-11-03
1753801509717942K891575COMPAT ENTERAL FEED PUMP 199235 & 199240LZH1989-09-12
2819431992124579K884408NAMIC DUAL BACKCHECK VALVEDTL1989-01-12
1753802071506512K873955NAMIC ANGIOGRAPHIC SYRINGEDXT1988-02-05
2819432071506512K873955NAMIC ANGIOGRAPHIC SYRINGEDXT1988-02-05
1753801007773174K872165ELASTO-GEL OCCLUSIVE DRESSINGFRO1987-06-26
2819431814086344K871157C.P.A.P. NASAL CANNULABZD1987-04-21
1753801061760368K854215DYNAFEEDKNT1985-12-02
311471820030936K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)FPA1985-05-30
2819431820030936K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)FPA1985-05-30
2819431703549780K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
1753801769634417K850959EQUIPMENT SNAP KOVERSJAA1985-04-09
2819431211358638K850898MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCERDRS1985-07-25
311471569487055K843726NAMIC ADB ANGIOGRAPHIC DUMP BAGDQO1984-10-18
2819431569487055K843726NAMIC ADB ANGIOGRAPHIC DUMP BAGDQO1984-10-18
2819431341482310K842829HIGH PRESSURE, 1 & 3 WAY STERILE DISPOSDTL1984-10-18
311471237950995K831974STOMACH TUBE LEVIN TUBEKNT1983-07-18
1753801237950995K831974STOMACH TUBE LEVIN TUBEKNT1983-07-18
1753801327146478K822100HIGH PRESSURE CONTRAST INJECTION LINEDQO1982-08-24
2819431327146478K822100HIGH PRESSURE CONTRAST INJECTION LINEDQO1982-08-24
311471858037780K821970DYNACOR URETHRAL CATHETER TRAYKOD1982-07-21
1753801858037780K821970DYNACOR URETHRAL CATHETER TRAYKOD1982-07-21
1753801113721935K820355DISPOSABLE DIAPHRAGM DOMESDRS1982-03-04
311471613593848K810156ARGYLE SALEM SUMP TUBEKNT1981-03-02
1753801613593848K810156ARGYLE SALEM SUMP TUBEKNT1981-03-02
2819431278351208K790082ARTERIAL EXTENSION SETDQO1979-01-25
311471080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
1753801080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
2819431080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
311471303436952K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
2819431178973917K232957Sterile and Non-Sterile Ultrasound GelsMUI2023-12-15
1753801554149066K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IOR2023-10-03
2819431236589041K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXX2023-03-24
2819432033383900K221278Transducer Probe CoverITX2023-01-11
1534202065529888K221278Transducer Probe CoverITX2023-01-11
1753801570094928K220365Gemini Sterilization WrapFRG2022-10-06
2819431570094928K220365Gemini Sterilization WrapFRG2022-10-06
1753801656590198K202668Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable ProteinKGO2020-12-19
311471611522810K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGO2020-11-18
2259571611522810K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGO2020-11-18
2819431797237996K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)FLL2020-11-23
2819431183190842K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateLZC2020-06-04
1753801278512692K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGO2020-04-06
1753801123173626K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGO2020-04-01
311471511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
1753801511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
2819431511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
311471300527836K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06
1753801300527836K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06
2819431212561040K191759Medline Quick Switch Valve with ENFit ConnectorPIF2019-12-04
3180161341077105K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeNGT2019-09-15
1753802063348723K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04
2819432063348723K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04
2819431943128152K190643Medline Electrocautery PencilGEI2019-05-06
2819431336537969K190224Medline Burn and Wound Dressing (OTC)FRO2019-03-08
2819431783956419K183577Medline Quick-Clear WandKNT2019-05-04
2819431886055192K183431Medline Digital Rectal Thermometer SheathFLL2019-06-14
311471460318586K183413TruWave Disposable Pressure TransducerDXO2019-05-01
2819431075815436K183335Medline Poly-Cath Red Polymer Urethral CatheterGBM2019-06-12
2819431663244919K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserNLM2019-04-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO252020-12-19
FRO232019-03-08
GEI132019-05-06
FYA102019-07-04
FRG82022-10-06
LZA82016-10-19
DRS82014-04-18
KKX82002-05-03
DQO72017-01-06
DTL72012-04-03
DQX72008-02-26
FXX62023-03-24
KNT62019-05-04
JOW52017-09-08
EZL52008-10-08
PIF42019-12-04
EZD42018-02-22
DXT42011-11-28
MGQ42004-03-25
LRO41996-09-16
CAH41993-01-26
IOR32023-10-03
FLL32020-11-23
KMJ32012-04-10
DWL32012-03-01
MMP32003-09-22
FPA32000-09-07
IZI31991-03-26
ITX22023-01-11
NGT22019-09-15
DQA22019-03-22
HRS22018-11-01
DXQ22016-06-13
JOJ22015-07-02
KMF22014-07-10
MSH22009-10-21
CCK22008-03-26
LYZ22006-12-05
KGN22006-06-19
GCJ21995-10-07