FDA.reportPublic FDA data

Unico

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Uniwin Precision Technology (Suzhou) Co., Ltd5N2026-01-01No. 26, Anfu Road, Dongbang Town Suzhou Jiangsu CN 215500
Unika Health Inc.5N2026-01-01880 W Maude Ave Sunnyvale CA US 94085
11249723000719497UNIVERSAL PLASTICS & ENGINEERING CO.1N2026-01-01678 LOFSTRAND LN. ROCKVILLE MD US 20850
15283191000122656UNITED STATES ENDOSCOPY GROUP, INC.1N2026-01-015976 Heisley Rd Mentor OH US 44060
20325423003646540UNICARE BIOMEDICAL, INC.1N2026-01-0123011 Moulton Pkwy Ste J11 Laguna Hills CA US 92653
20851531000160469united pacific company1Y2026-01-0111030 Weaver Ave South El Monte CA US 91733
20861093006266338UNITED EXCHANGE CORP.1Y2026-01-015836 Corporate Ave Ste 200 Cypress CA US 90630
20874233003707831UNITED SURGICAL LLC1Y2026-01-0111654 E 400 S Laotto IN US 46763
21336873000206619UNITY TOOL, INC.1N2026-01-0111660 TROY LN Osseo MN US 55369
21838902183890UNIPOWER CORP.1N2026-01-016024 Culligan Way Minnetonka MN US 55345
22166562216656UNIT PACK CO., INC.1N2026-01-017 Lewis Road Cedar Grove NJ US 07009
22497603000200590UNITED PRODUCTS & INSTRUMENTS, INC.1N2026-01-01182 Ridge Rd Ste E DAYTON NJ US 08810
23206233002740759UNITED PLASTIC MOLDERS, INC.1N2026-01-01105 E Rankin St JACKSON MS US 39201
25183992518399UNITED METAL FABRICATORS, INC.1N2026-01-011316 Eisenhower Blvd JOHNSTOWN PA US 15904
25228112522811UNIPACK LLC1N2026-01-013249 Old Frankstown Rd. Pittsburgh PA US 15239
26480853001544024UNIVERSAL CARE CORPORATION1Y2026-01-01Corujo Industrial Park Street C, Building 26 Bayamon PR US 00961
29186442918644UNITED CONTACT LENS INC1N2026-01-0119111 61st Ave Ne Unit 5 Arlington WA US 98223
96801681000295034UNITED POLY ENGINEERING PVT. LTD.1N2026-01-01D-13/3 OKHLA INDUSTRIAL AREA PHASE II NEW DELHI IN 110020
96816421000395711UNITED ORTHOPEDIC CORP.1N2026-01-01No. 16, Luke 1st Rd. Luzhu Dist., Kaohsiung TW 82151
30002155363000215536UNITED SYNTEK CORP.1Y2026-01-013557 Denver Drive Denver NC US 28037
30028084153002808415Unitron Hearing, a division of National Hearing Services Inc.1N2026-01-0120 BEASLEY DRIVE KITCHENER Ontario CA N2E 1Y6
30042177433004217743UNIVERSAL PUNCH CORP.1N2026-01-014001 W Macarthur Blvd Santa Ana CA US 92704
30045062043004506204UNITED BIOTECH1N2026-01-0145 W Jefryn Blvd, Suite E Deer Park NY US 11729
30050040413005004041UNITED PLASTICS GROUP(SUZHOU)CO.,LTD1N2026-01-01220 Xinghai Street, Suzhou Industrial Park, Jiangsu PR, China Suzhou Jiangsu CN 215021
30051974243005197424UNIVERSAL DIAGNOSTIC SOLUTIONS, INC.1Y2026-01-012410 La Mirada Dr Vista CA US 92081

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164291988295417K994078U1 HIP SYSTEMLPH2000-12-04
164291051536215K973854ORION ANTERIOR CERVICAL PLATE SYSTEMKWQ1998-03-16
2816631603132955K971842COAXIAL NEEDLEFCG1997-06-20
2816631972265114K962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEFGO1996-10-04
2816631424786589K951104ENDOBOOTOCU1995-04-06
3478731069699409K941607UCL MULTIFOCAL SOFT CONTACT LENSLPL1994-06-06
3170901449910629K940842UNIPOWER RECHARGEABLE BATTERY PACKLDD1994-09-07
3170901912390586K936141UNIPOWER RECHARGEABLE BATTERY PACKBXP1994-03-31
3170902044015275K935111UNIPOWERR RECHARGEABLE BATTERY PACKLDD1994-03-28
2816631987391451K925361BIOPSY FORCEPS, ELECTRICKGE1993-03-29
2816631972998649K924106BIOPSY FORCEPSKNW1992-11-24
2816631315575682K924105SNARE FLEXIBLEFDI1992-11-24
2816631957583790K924104CYTOLOGY BRUSHFDX1992-11-24
2816631768624008K882048MEDITRON ENDOLAV MODEL EL-100KNS1988-10-31
164291497405724K252725Stem Extension Line (U2 Total Knee System—PSA Type)JWH2025-09-25
164291483032710K252303Stem Extension Line (USTAR II System)KRO2025-08-22
2816631592045325K250842PADLOCK CLIP EFTR Kit (00713229)PKL2025-04-18
164291805971512K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaMBH2025-07-31
164291574124359K243466Conformity Stem Extension Line, #0LZO2025-01-06
3520142049247373K243146iCare APPMWI2025-02-03
164292048890347K243024Cellbrick Knee SpacerJWH2024-12-20
2816631569099039K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-10-11
164291406830160K242315Resolve Modular Revision Hip StemMEH2025-05-01
164291933049544K242249Conformity Stem Extension LineLZO2024-08-30
2816631850078922K241888Single-use Balloon Dilatation CatheterFGE2024-12-20
2816631153911514K241591Blue EyePLL2024-07-03
2816631401022612K240274PADLOCK CLIP EFTR Kit (00713229)PKL2024-09-17
2816631100316684K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-02-09
2816631702999148K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)ODC2023-10-20
2816631748047282K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)FBK2024-03-08
2816631284940712K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterODC2023-12-21
2816631832483470K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingOCX2023-08-01
3221761744450785K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidQUH2023-06-16
2816631815780635K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184GEH2022-12-02
164291100522714K222700Tibial baseplate, Tibial insertJWH2022-10-06
2816631546074787K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184GEH2022-08-18
164291681790615K221705U2 Total Knee System-PF+MBH2023-02-28
164291778287895K221675United U2 femoral head, 22mm delta ceramic headLPH2022-11-04
164291888200903K221149U-Motion II Acetabular System-Extension lineLZO2023-01-05
2816631670502007K220434Blue Eye (TS-905)PLL2022-08-12
2816631407648329K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)FDI2021-10-07
2816631008436251K212668Sclerotherapy NeedleFBK2022-02-23
2816631480018645K211787HemoclipPKL2022-03-03
164291837298604K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSJWH2021-04-21
2816632001320929K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating AdaptorODC2021-09-03
2816631623636461K203630BioGuard Air/Water and Suction ValvesODC2021-01-08
2816631112939101K202583BioShield biopsy valve EUS - LinearODD2020-11-06
2816632012467329K202104BioGuard EUS Air/Water and Suction ValvesODC2021-01-14
2816631620010312K201183Vortex Radial Spray CatheterGEH2020-12-07
2816631151910601K200745Lariat, Hot/Cold SnareFDI2020-04-21
551581660920284K200623OssGuideNPL2020-10-02
2816631635428015K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorODC2020-06-18
2816631149000532K192722Padlock Clip defect closure system, Padlock Pro-Select defect closure devicePKL2019-10-24
2816631165181450K192518Reusable Monopolar Active CordGEI2019-10-25
2816631816999963K192265gi-4000 Electrosurgical GeneratorGEI2020-05-21
2816631408215220K192059Bio Guard Air/Water & Suction ValvesODC2019-09-17
2816631910254462K191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileOCU2020-01-27
2816631859514875K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ2019-08-01
2816631743289442K191366Vacutore Air/Water Bottle TubingOCX2019-09-06
164291399634057K191056Conformity stem, cementedJDI2020-01-03
164291761236716K190100USTAR II SystemKRO2019-09-23
164292013733394K183312Conformity StemLZO2019-08-08
2816631583214832K182909Roth Net Retriever Product LineFDI2018-11-21
2816631373426677K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ2018-09-21
2816631182117687K181509Endorate Valve SetsOCX2018-07-06
2816631977266991K180731Ultramatrix EUS BalloonODG2018-04-19
2816631695924985K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure devicePKL2018-04-12
164291203045663K172833E-XPE Acetabular Components and U-Motion II Acetabular CupOQI2018-06-12
2816631288168915K172805gi-4000 Electrosurgical GeneratorGEI2017-10-23
2816631275892336K172729Polypectomy SnareFDI2018-05-21
2816631547044693K172727HemoclipPKL2018-04-16
164291524725915K172251UTS StemLPH2017-10-24
2816631384512632K171626truFreeze SystemGEH2017-08-30
164291106646877K170089U-Motion II Acetabular System— Additional sizesLZO2017-10-06
2816631099346662K163495AdvanCE capsule endoscope delivery deviceNEZ2017-03-10
2816631194053068K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon LinearFDF2017-01-06
164291179331573K163441Locking Cage, Full XPE CupLZO2017-08-25
2816631672834236K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONFEQ2017-01-04
164291255575622K163193UTF Stem, reduced, #0, #00LPH2017-06-08
164292050226791K162957U2 Femoral HeadLPH2017-07-17
164291230832577K161705U2 Total Knee System E-XPE productsJWH2017-03-16
164292031604696K161360U2 Total Knee System, PSA Tibial InsertJWH2017-02-01
164291711622049K152530UCP StemLZO2016-03-14
164291295280521K152439U2 Bipolar Implant and 22mm Femoral HeadKWY2016-04-07
164291379738981K152430All Poly Tibial ComponentJWH2016-04-12
2816631531044924K152035iSnare system-LariatFBK2015-10-15
2816631523576627K151889Infinity ERCP Sampling DeviceFDX2015-07-30
551581990310161K151344Cytoflex Tefguard Ti-Enforced MembraneNPK2015-11-19
164291730540811K151316U2 Hip Stem, Ti Porous Coated, MatrixLPH2015-08-13
2816631313029261K151197Lariat snareFDI2015-07-06
164291940618123K150832U2 Femoral Component, CR, Porous Coated, Additional SizesMBH2015-09-25
164291008384636K150829U2 Total Knee System- Additional SizesJWH2015-09-25
2816631414451220K140763MONOFILAMENT POLYPECTOMY SNAREFDI2014-04-24
2816631285165395K140405TORRENT IRRIGATION SYSTEMOCX2014-03-12
2816632061022367K140315US ENDOSCOPY DISTAL ATTACHMENT CAPOCX2014-04-04
164291865399487K140075U2 FEMORAL COMPONENT, CR, POROUS COATEDMBH2014-06-13
164291275029887K140073U2 FEMORAL COMPONENT, CR, CEMENTEDJWH2014-06-16
164291512793596K132752ULTRACONGRUENT INSERTJWH2014-03-13
164291005708096K132455U-MOTION II PS+ CUPLZO2013-09-03
164291234981047K132207UTF STEM-REDUCED, ADDITIONAL SIZESLPH2013-08-30
164291019799563K131864U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTJWH2014-01-15
164291880752535K131116U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERJWH2013-10-30
2816631209194241K130983GENII ARC SMART ARGON PROBEGEI2013-09-26
164291604565804K123550UTF STEM, REDUCEDLPH2013-05-01
3221761648667977K123450PHONAK TINNITUS BALANCEKLW2013-02-11
2816631557395228K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETFCX2013-08-06
164291930436064K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHLPH2012-10-10
2816631581185778K122462ROTH NET RETRIEVERFDI2012-09-11
164291281341913K122185U-MOTION II ACETABULAR SYSTEMLZO2013-02-22
164291172692436K122183AUGMENT AND SCREW, PSA TYPEJWH2013-02-05
164291053087513K121777U2 ACETABULAR CUP, PLASMA SPRAYLPH2012-07-18
2816631710528665K120814PADLOCK CLIP-12PKL2012-09-06
164292059035885K120507UNITED U2 FEMORAL COMPONENT, PS, #7JWH2012-05-04
2816631620846636K120084ENDOSCOPIC RETRIEVAL DEVICEOCZ2012-05-30
2816631002897698K113265GENII GI 4000 ELECTROSUGICAL GENERATORGEI2012-03-22
164291253835711K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTALZO2011-09-23
2816631460504093K111648BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORFCX2011-11-03
164291682108322K111546U2 HIP SYSTEMLPH2011-07-01
2816631394310233K111028EUS BALLOONFDF2011-11-01
164291753675326K110245UNITED UTF STEMLPH2011-08-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH202025-09-25
LPH142022-11-04
LZO102025-01-06
ODC92024-10-11
FDI92021-10-07
PKL72025-04-18
OCX62023-08-01
GEI52020-05-21
MBH42025-07-31
GEH42022-12-02
FEQ42019-08-01
FBK32024-03-08
FDF32017-01-06
KWY32016-04-07
FCX32013-08-06
KNS32010-09-07
LYC32009-11-25
KRO22025-08-22
MEH22025-05-01
PLL22024-07-03
ODD22020-11-06
OCU22020-01-27
FDX22015-07-30
LWJ22007-01-16
LPL22005-07-01
KWQ22005-05-12
LDD21994-09-07
MWI12025-02-03
FGE12024-12-20
QUH12023-06-16
NPL12020-10-02
JDI12020-01-03
OQI12018-06-12
ODG12018-04-19
NEZ12017-03-10
NPK12015-11-19
KLW12013-02-11
OCZ12012-05-30
KGN12011-02-02
OLR12009-07-24

NDC#

200 records. Showing 1-40. Next

PMA#

49 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#

118 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next