EMPI

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012200321	3012200321	EMPIRICAL BIOSCIENCE	1	N	2026-01-01	4535 40th Street SE Grand Rapids MI US 49508
3013114075	3013114075	EMPIRICAL SPINE, INC.	1	N	2026-01-01	18655 Madrone Pkwy Ste 180 Morgan Hill CA US 95037
3013358456	3013358456	EMPIRE SURGICAL INSTRUMENTS COMPANY	1	N	2026-01-01	786 Muradia Road Model Town Sialkot Punjab PK 51311
3030442070	3030442070	EMPIRE GENOMICS CORP.	1	N	2026-01-01	3370 Walden Avenue Suite 114 Depew NY US 14043
3015275189	3015275189	EMPIRE VISION OPTICAL CO., LTD.	1	N	2020-04-25	2F~3F, No. 28, & 2F, No. 26, Gongye E. 9th Rd. Paoshan Hsiang, H Paoshan Hsinchu - District TW 30075
3016674847	3016674847	EMPIRE MANAGED SOLUTIONS	1	Y	2020-04-25	901 Officers Row Vancouver WA US 98661

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
348597	1031938976	P220031	LimiFlex Dynamic Sagittal Tether	SGK	2026-02-12
238371	1596610661	K191929	UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens	LPL	2019-09-17
238371	2047172488	K182734	Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac	LPL	2019-05-16
206924	1138043494	K040052	FINE SURGICAL CIRCUMCISION CLAMP	HFX	2004-04-09
238450	2025205053
206924	1005807276
206924	1025242060
206924	1027339902
206924	1058013484
206924	1082130074
206924	1093489093
206924	1094287283
206924	1097072661
206924	1113925214
206924	1126704579
206924	1132425879
206924	1135059404
238450	1147722102
206924	1161604481
206924	1224227815
206924	1258907642
206924	1276069396
206924	1284092032
206924	1309559153
206924	1327076211
206924	1361982770
206924	1364441651
206924	1374209521
206924	1374271158
206924	1398415526
206924	1400856656
206924	1412431566
206924	1413762181
206924	1414021542
206924	1451196540
206924	1456031561
206924	1456616067
206924	1490245088
206924	1498174347
206924	1525672535
206924	1535572654
206924	1546667967
206924	1584877925
206924	1600541792
206924	1620233726
206924	1651535519
206924	1658063535
206924	1665299117
206924	1666568130
206924	1672970116
206924	1676410203
206924	1678748059
206924	1699409102
206924	1709455064
206924	1715223939
206924	1725332813
206924	1726839539
206924	1730560857
206924	1731901260
206924	1743905519
324300	1759217573
206924	1761555294
206924	1791784416
206924	1804056954
324300	1815976870
206924	1832866808
206924	1835171968
206924	1858634800
206924	1867724972
206924	1895125002
206924	1934118308
206924	1942873766
206924	1959342312
206924	1969199486
206924	1979592600
206924	1992673595
206924	1999888706
206924	2046602266
206924	2052537661
206924	2064973937

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LPL	2	2019-09-17
HFX	1	2004-04-09

NDC#

0.9 percent saline solution

EMPIRE GROUPS LLC

Sodium Chloride

PMN#

EMPI CONTINUUM

2010-03-05

EMPI

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

2009-06-05

EMPI

HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM

2007-11-16

EMPI

DUPEL TRANSPORT IONTOPHORESIS SYSTEM

2007-05-14

EMPI

SELECT TENS, MODEL 4600S

2007-01-22

EMPI

ENCOMPASS.NET

2006-01-25

EMPIRIC SYSTEMS, LLC

INFINITY PLUS ELECTROTHERAPY SYSTEM

2005-01-21

EMPI

INFINITY ELECTROTHERAPY SYSTEM

2004-12-17

EMPI

EMPI ACTION PATCH IONTOPHORESIS SYSTEM

2003-04-08

EMPI

300 PV COMPLETE ELECTROTHERAPY SYSTEM

2002-06-18

EMPI

DUPEL IONTOPHORESIS SYSTEM

1999-09-10

EMPI

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE

1998-12-28

EMPI

SMALL VAGINAL/RECTAL ELECTRODE

1998-11-03

EMPI

INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE

1997-08-14

EMPI

INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM

1997-06-30

EMPI

DUPEL II BUFFERED IONTOPHORESIS ELECTRODES

1997-05-30

EMPI

MINNOVA PELVIC FLOOR STIMULATION SYSTEM

1997-04-22

EMPI

EPIX VT

1997-04-14

EMPI

INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)

1997-01-24

EMPI

FOCUS MODEL 795 UNIT

1996-05-17

EMPI

INNOVA RECTAL STIMULATON ELECTRODE

1996-04-15

EMPI

EPIX XL TENS UNIT

1996-03-20

EMPI

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE

1995-12-06

EMPI

INNOVA PELVIC FLOOR STIMULATION SYSTEM

1995-01-20

EMPI

INNOVA VAGINAL EMG SENSING ELECTRODE

1994-12-29

EMPI

EMPI TAPE PATCHES

1994-08-23

EMPI

DUPEL IONTOPHORESIS DEVICE

1994-07-15

EMPI

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3

1991-11-15

EMPI

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2

1991-10-28

EMPI

TBD

1991-07-15

EMPI

IONTOPHORESIS DEVICE

1990-10-11

EMPI

TBD TENS REUSABLE ELECTRODE

1990-06-08

EMPI

MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE

1990-03-23

EMPI

MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE

1990-03-23

EMPI

TBD IONTOPHORESIS ELECTRODE

1990-02-26

EMPI

MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN

1989-12-21

EMPI

EMPI, MODEL 489, TENS

1989-06-01

EMPI

EMPI ISLAND TENS ELECTRODE

1989-03-16

EMPI

EMPI REUSEABLE PIN-STYLE TENS ELECTRODE

1989-03-16

EMPI

EMPI MULTIDAY TENS DISPOSABLE ELECTRODE

1989-03-16

EMPI

68 records. Showing 1-40. Next

Applications#

021486

EMPI

GUDID#

Instrument Tray - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Tensioner - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Tensioner Clip - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Driver - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Symbol Plate - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Holder - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Passer - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Limiflex Dynamic Sagittal Tether Instrument Set - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

Limiflex Dynamic Sagittal Tether - Gen 3

EMPIRICAL SPINE, INC.

2026-03-27

EMPIRE SURGICAL INSTRUMENTS COMPANY - 11-159

EMPIRE SURGICAL INSTRUMENTS COMPANY

2023-10-27

Empire - 4 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-14

Empire - 5 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-14

Empire - 4 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 4 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Case

Empire Managed Solutions LLC

2023-07-14

Empire - 5.5 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-13

Empire - 5.5 MIL Nitrile Gloves- Box

Empire Managed Solutions LLC

2023-07-13

EMPIRE SURGICAL INSTRUMENTS COMPANY - "IRIS SCISSORS 4.5"" STR PP"

EMPIRE SURGICAL INSTRUMENTS COMPANY

2022-09-01

EMPIRE SURGICAL INSTRUMENTS COMPANY - IRIS SCISSORS 4.5" STR PP

EMPIRE SURGICAL INSTRUMENTS COMPANY

2022-09-01

Ass'y, Kit, Hybresis Charging Station - 199586-001

EMPI, INC.

2014-09-24

Dupel Kit Iontophoresis Device - 199518-001

EMPI, INC.

2014-09-25

Kit Dupel II International complete w/safety socket - 199438-001

EMPI, INC.

2014-09-25

KIT, DUPEL II, w/SAFETY SOCKET - 199437-001

EMPI, INC.

2014-09-25

Iontophoresis Dupel Blue Large 4.0 mL - 199336-001

EMPI, INC.

2014-09-24

Iontophoresis Dupel Blue Medium - Standard 2.5 mL - 199335-001

EMPI, INC.

2014-09-24

Iontophoresis Dupel Blue Butterfly 2.0 mL - 199334-001

EMPI, INC.

2014-09-24

Iontophoresis Dupel Blue Small 1.5mL - 199332-001

EMPI, INC.

2014-09-24

Iontophoresis Electrode Medium Butterfly 2.0 mL Box of 12 - 199572-001

EMPI, INC.

2014-09-24

"Iontophoresis Electrode Large 4.0 mL 4""x4"" Box of 12" - 198810-001

EMPI, INC.

2014-09-24

"Iontophoresis Electrode Medium 2.0 mL 3""x3"" Box of 12" - 198809-001

EMPI, INC.

2014-09-24

"Iontophoresis Electrode Small 2.0 mL 3.75""x2.25"" Box of 12" - 198808-001

EMPI, INC.

2014-09-24

Action Patch Electrode ~ box of 4 - 199488-001

EMPI, INC.

2014-09-24

Hybresis Iontophoresis Patch, Medium/Standard, Box of 6 - 199589-001

EMPI, INC.

2014-09-24

Kit, Hybresis Controller - 199587-001

EMPI, INC.

2014-09-24