FDA.reportPublic FDA data

Hyland Software, Inc.

Matched from indexed company URL: HYLAND LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085969213008596921Hyland Software, Inc.1N2026-01-0112919 Earhart Avenue Auburn CA US 95602
30036161843003616184Hyland LLC1N2020-04-258009 34th Ave. S. Suite 900 Minneapolis MN US 55425
30051808273005180827Hyland LLC (formerly PACSGEAR, Perceptive, Lexmark Enterpri1N2020-04-254309 Hacienda Dr Ste 500 PLEASANTON CA US 94588
30087755943008775594HYLAND SOFTWARE, INC.1N2020-04-2528500 Clemens Rd Westlake OH US 44145

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
00850677007129Media Writer - Media Writer Software999-999-9999xxx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1207391734525873K954875ASPECT ACQUISITION MODULE (AAM)LMA1996-01-02
1238521057043218K101898R4 ACERT ULTRASOUND REPORTING SYSTEMLLZ2011-09-15
641081355781587K083618PACS SCANLLZ2009-01-28
1207391355781587K083618PACS SCANLLZ2009-01-28
1207391366660887K042484NAI TECH PRODUCTS MEDICAL DIGITAL RECORDERLMA2004-10-20
1238521715319708K000443REMOTE FETAL MEDICINE ULTRASOUND SYSTEMLLZ2000-04-24
1008231194713124
641081360762544
641081636802366

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42011-09-15
LMA22004-10-20

NDC#

NERVE TONIC STRESS RELIEF

Hyland's Inc.

calcium phosphate, iron, potassium phosphate, unspecified form, magnesium phosphate, dibasic trihydrate, and sodium phosphate

LEG CRAMPS

Hyland's Consumer Health Inc.

cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top

COLD

Hyland's Inc.

Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum

Seasonal Allergy Relief

Hyland's Inc.

onion, sodium chloride, histamine dihydrochloride, cucumber, galphimia glauca flowering top, and strychnos nux-vomica seed

NERVE TONIC

Hyland's Inc.

calcium phosphate, iron, potassium phosphate, unspecified form, magnesium phosphate, dibasic trihydrate, and sodium phosphate

Cold and Cough 4 Kids

Hyland's Inc.

ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, and GOLDENSEAL

ARNICA

Hyland's Inc.

arnica montana

Leg Cramps PM

Hyland's Inc.

oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur

MAGNESIA PHOS

Hyland's Inc.

magnesium phosphate, dibasic trihydrate

LEG CRAMPS

Hyland's Inc.

cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top

COUGH BABY

Hyland's Inc.

ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root

Tiny Cold

Hyland's Inc.

eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide

Restful Legs

Hyland's Inc.

arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc

EARACHE DROPS

Hyland's Inc.

belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur

4 Kids Complete Cold and Mucus

Hyland's Inc.

bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide

Defend Cold and Mucus

Hyland's Inc.

BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, and SILICON DIOXIDE

DEFEND Sinus

Hyland's Inc.

OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS

Leg Cramps

Hyland's Inc.

ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP

Sleep

Hyland's Inc.

HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC

CALMS FORTE

Hyland's Inc.

avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower

CALMS FORTE

Hyland's Inc.

avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower

BABY MUCUS PLUS COLD RELIEF

Hyland's Inc.

bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide

Baby Oral Pain Relief

Hyland' Inc.

oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla

Baby Nighttime Oral Pain Relief

Hyland' Inc.

Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude

Calm

Hyland's Inc.

TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE

Rest

Hyland's Inc.

SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS and VALERIAN

Restful Legs PM

Hyland's Inc.

ANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPORE

Baby Nighttime Mucus Plus Cold Relief

Hyland's Inc.

CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA and MATRICARIA CHAMOMILLA

4 Kids Cold and Mucus Nighttime

Hyland's Inc.

EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE and SULFUR

BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME

Hyland's Inc.

calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla

4 Kids Cold and Cough Nighttime

Hyland's Consumer Health Inc.

ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS and GOLDENSEAL

83 records. Showing 1-40. Next

PMN#

TEST CELLS

1979-05-16

HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES

GUDID#

NilRead - The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used.On mobile platforms, this device is not intended for diagnostic use.

Hyland Software Canada ULC

2020-02-07

PACSgear Enterprise Server - PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.

HYLAND LLC

2021-02-26

PACS Scan Mobile - The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use.

HYLAND LLC

2019-08-30