HORIZON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040837363004083736HORIZONS INTL. CORP.1N2026-01-01ZETA FREE ZONE PARK LA VALENCIA HEREDIA CR --
30064574013006457401HORIZON SCIENTIFIC, INC1N2026-01-01125 Varnfield Drive Summerville SC US 29483

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810083952642COREPOINT - White / SS, Solid Door, Top Mount Freezers - 23 cuft1-800-648-4041technicalservice@horizonscientific.com
00810083952659COREPOINT - White / SS, Solid Door, Top Mount Freezers - 49 cuft1-800-648-4041technicalservice@horizonscientific.com
00810083952703COREPOINT - White / SS, Glass Door, Top Mount Refrigerators - 23 cuft W/ Chart Recorder1-800-648-4041technicalservice@horizonscientific.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
190031108302833K083049TORNADO ROTATABEL SNARE AND POLYP CATCHERFDI2008-12-23
190031667045639K022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLESEOQ2002-08-12
190031464112386K022268HORIZONS REUSABLE POLYPECTOMY SNARESFDI2002-10-25
190031325354598K022243HORIZONS REUSABLE HOT BIOPSY FORCEPSKGE2002-10-25
190031183409098K021998HORIZONS CYTOLOGY BRUSHFDX2002-07-12
190031777246577K021706HORIZONS HOT BIOPSY FORCEPSKGE2002-06-21
190031452890221K011667HORIZONS INTERNATIONAL POLYPECTOMY SNARESFDI2001-08-16
190032033290565K010448HORIZONS INTERNATIONAL VARICES INJECTION NEEDLESFBK2001-05-16
190031945462154K002236HORIZONS PAPILLOTOMEKNS2001-01-23
190031649670401K002235HORIZONS ERCP CANNULAFGE2001-01-23
190031042701733
190031110653348
190031292805142
190031406561373
190031695439130
2984761794423134
190031986001693

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FDI32008-12-23
KGE22002-10-25
EOQ12002-08-12
FDX12002-07-12
FBK12001-05-16
KNS12001-01-23
FGE12001-01-23

NDC#

Ravicti

Horizon Therapeutics USA, Inc.

glycerol phenylbutyrate

Krystexxa

Horizon Therapeutics USA, Inc.

pegloticase

BUPHENYL

Horizon Therapeutics USA, Inc.

sodium phenylbutyrate

Buphenyl

Horizon Therapeutics USA, Inc.

sodium phenylbutyrate

Krystexxa

Horizon Therapeutics USA, Inc.

pegloticase

PROCYSBI

Horizon Therapeutics USA, Inc.

Cysteamine bitartrate

PROCYSBI

Horizon Therapeutics USA, Inc.

Cysteamine bitartrate

ACTIMMUNE

Horizon Therapeutics USA, Inc.

Interferon gamma-1b

TEPEZZA

Horizon Therapeutics USA, Inc.

teprotumumab

PROCYSBI

Horizon Therapeutics USA, Inc.

Cysteamine bitartrate

PROCYSBI

Horizon Therapeutics USA, Inc.

Cysteamine bitartrate

UPLIZNA

Horizon Therapeutics USA, Inc.

Inebilizumab

PMA#

PMN#

VORTEX MP

2003-09-12

Horizon Medical Products, Inc.

AMYLASE

1994-04-06

HORIZON DIAGNOSTICS, INC.

Applications#

761143

HORIZON THERAPEUTICS IRELAND

GUDID#