FDA.reportPublic FDA data

Lisa Ewing

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96118633002807648Lisa Ewing1N2026-01-012875 Railroad St Pittsburgh PA US 15222
30123584173012358417Lisa Ewing1N2026-01-012875 Railroad St Pittsburgh PA US 15222
30133022423013302242Lisa Ewing1N2026-01-012875 Railroad St Pittsburgh PA US 15222
30221426283022142628Lisa Ewing1N2026-01-012875 Railroad St Pittsburgh PA US 15222

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1901971255819360K994202ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEMHWC2000-02-25
98691695895356K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
2782921894575557K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1901971905238536K992945RCI FIXATION SCREWS (WITH ASSORTED SIZES)HWC1999-11-18
1901972062320165K992396BIORCI SCREWHWC2000-01-12
1901971289235775K991218ORATEC BIPOLAR ABLATION PROBESGEI1999-09-13
1901971740962577K980155ENDOBUTTON CONTINUOUS LOOPGAT1998-04-01
1901971616162045K972599ACUFEX SCREW CANNULAHWC1997-09-19
1901971024767135K972326PEBA ANCHOR/SUTURE COMBINATIONMBI1998-02-06
1901971332795625K964215ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEMHRX1996-12-20
3043371349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
3043371276675979K962137GENESIS II CONSTRAINED SYSTEMJWH1996-08-02
1901972056229681K961649ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHERHWC1996-07-16
2782921802714596K954712INTRAMEDULLARY HIP SCREW (MODIFICATION)KTT1995-10-31
3043371049157024K951987GENESIS II TOTAL KNEE SYSTEMJWH1995-08-22
2782921650273108K951987GENESIS II TOTAL KNEE SYSTEMJWH1995-08-22
1901971931277773K951859ACUFEX ENDOBUTTON PACKHRX1995-06-09
1901971496413016K951451PEBA ANCHOR (MULTIPLE SIZES)MBI1995-10-31
1901971102207805K945236AIMS CANNULATED ACL SCREW (7MM DIAMETER)HWC1995-02-03
1901971308094858K941364ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMSHRX1994-05-16
1901972069635917K933948ACUFEX ENDOBUTTON SYSTEMMAI1994-07-21
2782921549184236K933027THE MODULAR NAILHSB1994-02-22
1901971374755677K931621ACUFEX PRO-PAC AND ISO-PACHRX1994-01-21
1901971732477741K925573ACUFEX T-BARHRX1993-05-05
1901971782083976K925437ACUFEX CANNULATED BONE TUNNEL PLUGSHRX1992-12-24
1901971015335990K921481INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIRHWC1993-08-24
1901971851711573K920621ACUFEX PASSING PINS AND SURGICAL WIREHWQ1993-05-05
1901971112463218K910186WYMAN SUTURE WASHERHTN1991-07-25
1901971735915857K885311MENISCUS MENDER II LOOPHWQ1989-02-09
1901971767208072K881224ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEGAE1988-06-01
98691014577239K870961RICHARDS EXTERNAL FIXATION SYSTEMKTT1987-03-19
1901971689647048K834370MULHOLLAN ARTHROSCOPIC NEEDLE CARRIERLXH1984-02-27
1901971890985285K832277ACUFLEX LEVY ACL DRILL GUIDE SYSHRX1983-08-16
1901971143169571K254122FLOW FLEXTEND Wand (72290039)GEI2026-03-30
1901971190118126K253680LYNX COBLATION Laryngeal Wand (72290254)GEI2026-03-25
1901971831116085K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)MBI2025-06-25
1901971317316430K242631REGENETEN™ Bioinductive ImplantOWY2024-11-26
1901971739073959K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blueMBI2024-06-20
1901971230510370K240964FLOW 90? WandGEI2024-05-08
1901971489315545K233730Footprint Mini PK, 3.5mm Suture AnchorMBI2024-01-17
1901971016146170K232457Q-FIX ULTRA All-Suture AnchorMBI2023-09-08
1901971105907153K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)MBI2023-08-04
1901971626037896K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)MBI2023-08-09
1901971068324042K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)GEI2023-06-26
3043371105321410K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesJWH2023-05-04
1901971182458708K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation DeviceMBI2023-02-17
1901971424111723K222501Regeneten Bioinductive ImplantOWY2023-05-11
1901971167971066K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION SystemGEI2022-09-01
3043371604135869K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsJDO2022-09-29
3043371565111099K211176Smith & Nephew Hip SystemsLPH2022-07-01
3043371410259185K210837Smith & Nephew Plates and ScrewsHRS2021-06-29
1901971088498162K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandGEI2021-06-24
1901971814913241K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy SystemQFC2021-12-14
3043371456186468K203405EVOS Large Fragment Plating SystemHRS2021-01-27
1901972034104123K203393FAST-FIX FLEXGAT2021-02-01
1901971557394300K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation SystemGEI2020-12-18
3043371186759200K201918EVOS Large Fragment Plating SystemHRS2020-11-16
1901971426028258K193558HEALICOIL Knotless Suture AnchorsMAI2020-03-18
1901971093626520K192027WEREWOLF COBLATION System, COBLATION HALO WandGEI2019-12-20
2782921234389342K191002OR3O Dual Mobility SystemLPH2019-10-31
2782921280508946K183346FLOW 90 WandGEI2019-01-24
1901971654002112K183346FLOW 90 WandGEI2019-01-24
1901971680965259K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT2018-08-01
1901971851667318K181746MICRORAPTOR Knotless Suture AnchorMAI2018-09-28
2782921432472773K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesGEI2018-05-01
1901971560182984K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesGEI2018-05-01
1901971366134076K180531NovoStitch Pro Meniscal Repair SystemGAT2018-03-29
1901972056842773K180361MICRORAPTOR REGENESORB Suture AnchorMAI2018-05-30
3043371465236243K172262EVOS Small Fragment Plating SystemHRS2017-08-23
1901971115066776K172165Q-Fix Suture AnchorMBI2017-08-17
2782921635751748K172165Q-Fix Suture AnchorMBI2017-08-17
2782921277354382K171934Birmingham Hip (BH) Dual Mobility InsertLPH2017-11-30
3043371189822400K170887EVOS Small Fragment Plating SystemHRS2017-04-24
3043371183987777K170648ANTHEM CR Total Knee SystemJWH2017-05-11
1901971535339986K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and UnloaderGAT2017-01-06
1901971337601504K163034SUTUREFIX Curved Suture AnchorMBI2016-12-07
1901971094452088K162996INVISIKNOT Ankle Syndesmosis Repair KitHTN2017-06-08
1901972015842778K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)GEI2016-09-29
3043371018470269K162078EVOS Small Fragment Plating SystemHRS2016-11-18
1901971895639075K162074Werewolf RF20000 Controller, FLOW 50 WandGEI2016-08-22
2782921920777023K161481Ambient HipVac 50 Wand with Integrated Finger SwitchesGEI2016-10-21
1901972065338760K161481Ambient HipVac 50 Wand with Integrated Finger SwitchesGEI2016-10-21
1901971278664036K153675Paragon T2 Wand with Integrated CableGEI2016-01-15
1901971692766566K153669MultiFIX S Ultra Knotless Fixation SystemMBI2016-01-19
1901971652482797K153313SpeedLock Knotless Fixation SystemMBI2015-12-11
2782921519710236K153186Adjustable Fixation DeviceMBI2016-01-28
1901971641269657K153186Adjustable Fixation DeviceMBI2016-01-28
1901971685511246K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture AnchorsMBI2015-12-02
1901971683875164K151897MultiFIX® P Knotless Fixation DeviceMBI2015-08-06
1901971787884134K151660MultiFIX S Knotless Fixation SystemMBI2015-07-16
1901971021615067K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra FaMAI2015-07-28
2782921647047711K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HALZO2015-04-20
1901971884299043K143235RF20000a Controller, FLOW 50 WandGEI2015-10-23
2782921997731581K143235RF20000a Controller, FLOW 50 WandGEI2015-10-23
1901971373306106K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated CableGEI2014-11-19
3043371989208618K142807ANTHEM PS Total Knee SystemJWH2014-12-22
1901971408007065K140992ARTHROCARE NASASTENT CMC NASAL DRESSINGLYA2014-06-16
3043371977841786K140814EVOS MINI-FRAGMENT PLATING SYSTEMHRS2014-05-07
1901971717748435K140604MULTIFIX S KNOTLESS FIXATION SYSTEMMBI2014-05-14
1901971474117819K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCHGEI2014-06-10
2782921870874679K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCHGEI2014-06-10
1901971493071898K140300COLLAGEN TENDON SHEET-DDI (CTS-DDI)OWY2014-03-26
1901971609004926K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTUMBI2014-01-16
2782921899352560K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTUMBI2014-01-16
1901971803713762K133606N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILLMBI2014-04-01
2782921653089512K132435SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSLZO2013-10-22
1901971944153550K132357SMITH & NEPHEW ULTRATAPEGAT2013-10-30
1901971388585384K132079TFCC FAST-FIX KITGAT2013-12-05
1901971175254011K131635ROTATION MEDICAL BONE STAPLE (RMB STAPLE)MBI2013-08-29
1901971602172113K131205ARTHROCARE HEAD AND NECK COBLATION WANDGEI2013-08-09
2782921223691108K130728POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HALZO2013-10-10
2782921158187419K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRMBI2013-02-27
1901971247996544K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRMBI2013-02-27
2782922069843209K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONJDI2013-06-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI582025-06-25
GEI492026-03-30
GAT202021-02-01
HWC162008-10-01
JWH142023-05-04
HRS122021-06-29
MAI102020-03-18
HRX102001-06-28
LPH92022-07-01
LZO62015-04-20
MBL42012-04-27
KTT42010-09-27
OWY32024-11-26
OLO32012-11-15
HTN22017-06-08
LYA22014-06-16
JDW22012-06-07
HAW22010-05-06
HSB22009-07-29
HSD22007-03-02
OCW22006-10-02
HWQ21993-05-05
JDO12022-09-29
QFC12021-12-14
JDI12013-06-28
FTM12013-01-08
HSX12012-01-05
PHX12008-09-05
JDS12004-02-20
KWY12003-01-23
JDR12000-04-03
GAE11988-06-01
LXH11984-02-27