SUSTOL
granisetron
Hero
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013481097 | 3013481097 | HERON THERAPEUTICS, INC. | 1 | N | 2026-01-01 | 100 Regency Forest Dr Ste 300 Cary NC US 27518 |
| 3014660737 | 3014660737 | HERO HEALTH, Inc. | 1 | N | 2026-01-01 | 90 Broad Street Floor 2 New York NY US 10004 |
| 3031571464 | 3031571464 | Herotron E-Beam Service GmbH | 1 | N | 2026-01-01 | Guardianstrabe 6-10 Bitterfeld Saxony-Anhalt DE 06766 |
| 3013752208 | 3013752208 | HERO COSMETICS LLC | 1 | Y | 2020-04-25 | 154 Grand Street New York NY US 10013 |
| 3015992043 | 3015992043 | HERO DENTAL SUPPLIES | 1 | Y | 2020-04-25 | 16205 NW Bethany Court #112 Beaverton OR US 97006 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 329684 | 1989039762 | K033880 | ELECTRO-LUBE | GEI | 2004-03-10 |
| 329684 | 1057636392 | ||||
| 293113 | 1425374229 | ||||
| 293113 | 1520542460 | ||||
| 293113 | 1533702760 | ||||
| 293113 | 1819758762 | ||||
| 329684 | 1874687633 | ||||
| 219714 | 2012312942 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 1 | 2004-03-10 |
NDC#
CINVANTI
aprepitant
APONVIE
APREPITANT
ZYNRELEF
BUPIVACAINE and MELOXICAM
ZYNRELEF
BUPIVACAINE and MELOXICAM
Hero Force Shield SPF 30
ZINC OXIDE
PMN#
AccurSound Electronic Stethoscope (AS101)
Heroic Faith International , Ltd.
AccurSound Electronic Stethoscope AS-101
Heroic Faith International , Ltd.
Applications#
GUDID#
Heroic Faith - Airmod is an Android-based software application designed to aid healthcare professionals by monitoring a patient’s breathing in real time. It can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmod is intended for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation in which the depth of sedation ranges from moderate and deep sedation/anesthesia to general anesthesia and the consciousness status of patients ranges from clear to unarousable. Airmod is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia.
2026-04-22
Mighty Patch - MP001EU
2022-04-01
Mighty Patch - MP008
2022-04-01
Mighty Patch - MP006
2022-04-01
Mighty Patch - MP005
2022-04-01
Mighty Patch - MP004
2022-04-01
Mighty Patch - MP004EU
2022-04-01
Mighty Patch - MP003
2022-04-01
Mighty Patch - MP002
2022-04-01
Mighty Patch - MP001
2022-04-01
Mighty Patch - MP016
2022-04-01
Mighty Patch - MP015
2022-04-01
Mighty Patch - MP014
2022-04-01
Mighty Patch - MP006EU
2022-04-01
Mighty Patch - MP002EU
2022-04-01
Mighty Patch - MP012
2022-04-01
Mighty Patch - MP013
2022-04-01
Mighty Patch - MP009
2022-04-01
Mighty Patch - MP021
2022-10-13
Mighty Patch - HK007
2022-10-13
Mighty Patch - HK003
2022-10-13
Mighty Patch - HK002
2022-10-13
Mighty Patch - MPB001
2022-10-13
SUSTOL Co-packaged Kit - NA
2025-03-18
Heroic Faith - The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart,lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. Thedevice is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
2023-09-01
Heroic Faith - The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcareprofessionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart,lungs, arteries, veins, and other internal organs.The microphone-equipped disposable sensor detects and amplifies the sounds from the patient’sbody. The auscultation sound is digitally processed and filtered, electronically amplified in thehub unit. The anti-noise function reduces ambient noise and echoes, then transferred to theearpiece.The multi-channel design allows healthcare professionals to attach disposable sensors ontopatient’s body, by switching modes from handheld single-channel recording to four-channelstationery and continuously auscultation based on different requirements of clinical applicationsor physical assessments.
2023-09-18
Heroic Faith - The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcareprofessionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart,lungs, arteries, veins, and other internal organs.The microphone-equipped disposable sensor detects and amplifies the sounds from the patient’sbody. The auscultation sound is digitally processed and filtered, electronically amplified in thehub unit. The anti-noise function reduces ambient noise and echoes, then transferred to theearpiece.The multi-channel design allows healthcare professionals to attach disposable sensors ontopatient’s body, by switching modes from handheld single-channel recording to four-channelstationery and continuously auscultation based on different requirements of clinical applicationsor physical assessments.
2023-09-18
ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement - N/A
2024-11-07
ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement - N/A
2024-11-07
ZYNRELEF 20 mL Vial Access Needle (VAN) - ZYNRELEF 20 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
2024-10-02
ZYNRELEF 10 mL Vial Access Needle (VAN) - ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
2024-10-02
ZYNRELEF Replacement 12 mL Luer Lock Syringes - Base package contains quantity of 8 of the 12 mL Luer Lock Syringes.
2021-07-15
ZYNRELEF Replacement Vented Vial Spikes - Base package contains quantity of 5 vented vial spikes.
2021-07-15
ZYNRELEF Luer Lock Applicator - N/A
2021-07-15
ZYNRELEF Luer Lock Applicator - N/A
2021-07-15