BEARCO

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007074233	3007074233	BEAR MEDIC CORPORATION	1	N	2026-01-01	1361 Daigo Daigomachi, Kuji-gun Ibaraki JP 319-3526
3010603857	3010603857	BEAR AND WILSON TECHNOLOGY, INC.	1	N	2026-01-01	No. 356, Lin Sen Rd. Wu Feng Dist. Taichung TW 41352
3011077581	3011077581	BEAR DOWN BRANDS, LLC	1	Y	2026-01-01	1938 W Malvern Ave Fullerton CA US 92833
3015715211	3015715211	BEARPAC MEDICAL, LLC	1	N	2026-01-01	124 WEST POINT RD Moultonborough NH US 03254
3021680161	3021680161	BEAR-ENT, LLC	1	Y	2026-01-01	274 Lancaster Ave., Suite 208 Malvern PA US 19355
3028172072	3028172072	BEAR DOWN BRANDS, LLC CHINO WAREHOUSE	1	Y	2026-01-01	5985 Schaefer Ave Chino CA US 91710

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
89038	1774962049	K961100	MICRO ANASTOMOSIS CLAMP	DXC	1996-06-19
232837	1950220372	K230319	Passio Pump Drainage System	PNG	2023-11-24
173586	1763564358	K223308	HEATING TENS/EMS, FT-810R	NUH	2023-05-13
340567	1763564358	K223308	HEATING TENS/EMS, FT-810R	NUH	2023-05-13
173586	1336893286	K221384	Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2	NUH	2022-06-11
340567	1336893286	K221384	Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2	NUH	2022-06-11
232837	1735564332	K201404	Passio Pump Drainage System	DWM	2020-11-20
232837	1927100615	K190292	Passio Pump Drainage System	DWM	2019-07-25
89038	2053100056	K161315	Vein Clamps, Artery Clamps	DXC	2016-08-18
173586	1541595881	K151284	Electric Double Breast Pumps	HGX	2015-12-21
340567	1541595881	K151284	Electric Double Breast Pumps	HGX	2015-12-21
173586	1589468544	K141299	OTC COMBO TENS/EMS SYSTEM	NUH	2014-11-14
340567	1589468544	K141299	OTC COMBO TENS/EMS SYSTEM	NUH	2014-11-14
173586	1038522033	K131921	ELECTRONIC PULSE STIMULATOR	NUH	2013-11-15
340567	1038522033	K131921	ELECTRONIC PULSE STIMULATOR	NUH	2013-11-15
173586	1339385467	K131720	HIVOX SELF ADHESIVE ELECTRODE GEL PADS	GXY	2014-07-25
340567	1339385467	K131720	HIVOX SELF ADHESIVE ELECTRODE GEL PADS	GXY	2014-07-25
173586	1320118267	K092958	AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES	FLL	2009-12-02
340567	1320118267	K092958	AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES	FLL	2009-12-02
173586	1152153430	K091757	OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407	NUH	2010-02-05
340567	1152153430	K091757	OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407	NUH	2010-02-05
173586	1657249915	K082065	WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP	GXY	2009-04-10
340567	1657249915	K082065	WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP	GXY	2009-04-10
89038	1105440690	K042367	NYLON THREADED NEEDLE	GAR	2004-10-14
173586	1027306819
164218	1037733129
164218	1219817149
164218	1268652566
164218	1327069937
164218	1380223171
164218	1556565419
164218	1577263803
164218	1654537461
164218	2067732442
302611	1008720640
173586	1020498834
340567	1020498834
302611	1029482751
302611	1038525048
302611	1053920836
302611	1060218193
302611	1060696859
302611	1067871861
302611	1072995718
302611	1129800232
302611	1157410314
302611	1162132637
302611	1167321918
302611	1170124415
302611	1208661991
302611	1217941951
302611	1227040943
302611	1227722365
173586	1267565537
340567	1267565537
302611	1268915741
302611	1291126612
302611	1299128771
302611	1318647598
302611	1336869991
302611	1342831896
302611	1362036280
173586	1376076074
340567	1376076074
302611	1384918529
302611	1388100183
302611	1409810408
302611	1417519615
302611	1423595140
302611	1434061581
302611	1441058350
302611	1457556432
302611	1499170897
302611	1516252222
302611	1532948349
302611	1579523200
302611	1652080951
302611	1661582305
302611	1667950871
302611	1681287107
173586	1690872278
340567	1690872278
302611	1706857349
302611	1715568146
302611	1738027276
302611	1778299365
302611	1784307506
302611	1810445287
302611	1818683233
302611	1830685657
302611	1831774264
302611	1831957196
302611	1844227756
302611	1858377796
164218	1870949780
302611	1890549140
173586	1897938272
340567	1897938272
302611	1899380301
302611	1931040822
302611	1945510832
302611	2010867724
173586	2012203568
340567	2012203568
302611	2019788775
173586	2020421760

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NUH	10	2023-05-13
DXC	4	2016-08-18
GXY	4	2014-07-25
FLL	4	2009-12-02
DWM	3	2020-11-20
HGX	2	2015-12-21
GAR	2	2004-10-14
PNG	1	2023-11-24

PMN#

Passio Pump Drainage System
2023-11-24
Bearpac Medical
Passio Pump Drainage System
2020-11-20
Bearpac Medical
Passio Pump Drainage System
2019-07-25
Bearpac Medical
BEAR CUB 750 PSV
1999-09-16
BEAR MEDICAL SYSTEMS, INC.
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
1998-11-20
BEAR MEDICAL SYSTEMS, INC.
BEAR 7 VENTILATOR
1992-06-11
BEAR MEDICAL SYSTEMS, INC.
BEAR CEM CONTROLLER
1990-08-03
BEAR MEDICAL SYSTEMS, INC.
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
1990-01-22
BEAR MEDICAL SYSTEMS, INC.
VHS 820 HUMIDIFIER, MODIFICATION
1989-07-14
BEAR MEDICAL SYSTEMS, INC.
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
1989-03-30
BEAR MEDICAL SYSTEMS, INC.
BEAR EVC-100 CONTROLLER
1988-09-30
BEAR MEDICAL SYSTEMS, INC.
BEAR 3 VENTILATOR
1988-08-04
BEAR MEDICAL SYSTEMS, INC.
BEAR NVM-1
1988-02-12
BEAR MEDICAL SYSTEMS, INC.
BEAR VH-820 HUMIDIFIER
1987-12-02
BEAR MEDICAL SYSTEMS, INC.
BEAR JET VENTILATOR FOR USE DURING (ESWL)
1987-06-15
BEAR MEDICAL SYSTEMS, INC.
TRI-SERVICE OMV VAPORIZER
1987-06-05
BEAR MEDICAL SYSTEMS, INC.
AM1000
1987-05-04
BEAR MEDICAL SYSTEMS, INC.
VAPLOK
1987-02-03
BEAR MEDICAL SYSTEMS, INC.
PENLON CIRCLE SYSTEM
1987-02-03
BEAR MEDICAL SYSTEMS, INC.
PTR MK II VENTILATOR
1986-05-21
BEAR MEDICAL SYSTEMS, INC.
BEAR NICU-1
1985-09-11
BEAR MEDICAL SYSTEMS, INC.
AIR COMPRESSOR
1985-05-28
BEAR MEDICAL SYSTEMS, INC.
BEAR JET-150 VENTILATOR
1984-07-26
BEAR MEDICAL SYSTEMS, INC.
VH820 HUMIDIFIER
1984-07-17
BEAR MEDICAL SYSTEMS, INC.
PENLON ANESTHESIA VENTILATOR SERIES 300
1984-06-26
BEAR MEDICAL SYSTEMS, INC.
PENLON TRANSPORT VENTILATOR SERIES 350
1984-06-26
BEAR MEDICAL SYSTEMS, INC.
BEAR 33
1984-05-23
BEAR MEDICAL SYSTEMS, INC.
CONTINUOUS VENTILATOR
1984-04-06
BEAR MEDICAL SYSTEMS, INC.
BEAR VENTI--VOICE
1984-01-24
BEAR MEDICAL SYSTEMS, INC.
BEAR JET 150 VENTILATOR
1983-04-12
BEAR MEDICAL SYSTEMS, INC.
BEAR VM-90 VENTILATION MONITOR
1982-11-16
BEAR MEDICAL SYSTEMS, INC.

GUDID#

Pure Enrichment - PEGELPAK
BEAR DOWN CONSULTING
2023-04-07
PURE ENRICHMENT - Dual electric breast pump.
BEAR DOWN CONSULTING
2018-12-03
Pure Enrichment - PEHUTRB2G-W
BEAR DOWN CONSULTING
2025-09-08
PURE ENRICHMENT - PEPULSE-RT
BEAR DOWN CONSULTING
2022-07-22
Verilux - VT54WW6
BEAR DOWN CONSULTING
2024-10-07
Verilux - VT20WW1
BEAR DOWN CONSULTING
2024-09-22
Pure Enrichment - PEHPWD2-PE
BEAR DOWN CONSULTING
2024-08-28
PURE ENRICHMENT - Trio tens & ems muscle stimulator + heat.
BEAR DOWN CONSULTING
2023-12-15
PURE ENRICHMENT - Trio tens & ems muscle stimulator + heat.
BEAR DOWN CONSULTING
2023-12-15
PURE ENRICHMENT - Reusable electrode gel pads.
BEAR DOWN CONSULTING
2023-12-14
PURE ENRICHMENT - Reusable electrode gel pads.
BEAR DOWN CONSULTING
2023-12-14
PURE ENRICHMENT - Reusable electrode gel pads.
BEAR DOWN CONSULTING
2023-12-14
PURE ENRICHMENT - Reusable electrode gel pads.
BEAR DOWN CONSULTING
2023-12-14
Verilux - VT22WW3
BEAR DOWN CONSULTING
2023-04-23
Verilux - VT53WW4
BEAR DOWN CONSULTING
2023-04-28
Verilux - VT41WW3
BEAR DOWN CONSULTING
2023-04-28
Verilux - VT39WW1
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT43CG3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT43MB3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT37WW1
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT52WW3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT42WW3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT43WW3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT31WW3
BEAR DOWN CONSULTING
2023-05-17
Verilux - VT32WW3
BEAR DOWN CONSULTING
2023-05-17
Pure Enrichment - PEFIRGT-IG
BEAR DOWN CONSULTING
2023-07-21
Pure Enrichment - PEFIRNK-IG
BEAR DOWN CONSULTING
2023-07-21
Pure Enrichment - PEFIRBK-IG
BEAR DOWN CONSULTING
2023-07-21
Pure Enrichment - PEHPRDBK-GS
BEAR DOWN CONSULTING
2023-07-21
Pure Enrichment - PEHUTRB-BDL2P
BEAR DOWN CONSULTING
2023-06-30
Pure Enrichment - PEHUTRB-BDL
BEAR DOWN CONSULTING
2023-06-30
PURE ENRICHMENT - TENS & EMS UNIT
BEAR DOWN CONSULTING
2017-02-11
PURE ENRICHMENT - PETNEMHT
BEAR DOWN CONSULTING
2022-08-12
PURE ENRICHMENT - TENS UNIT
BEAR DOWN CONSULTING
2016-10-19
PURE ENRICHMENT - TENS UNIT
BEAR DOWN CONSULTING
2016-10-19
Pure Enrichment - PECAIR24-G
BEAR DOWN CONSULTING
2023-05-22
Pure Enrichment - PECAHP24-G
BEAR DOWN CONSULTING
2023-05-22
Pure Enrichment - PEHPWIDE-CA
BEAR DOWN CONSULTING
2023-05-22
Pure Enrichment - PEHPVAL-CAG
BEAR DOWN CONSULTING
2023-05-22
Pure Enrichment - PEHPAD24-CAG
BEAR DOWN CONSULTING
2023-05-22

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