FDA.reportPublic FDA data

Bayer HealthCare, LLC

Matched from indexed company URL: Bayer Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22432522243252Bayer HealthCare, LLC1N2026-01-0136 Columbia Rd Morristown NJ US 07960
22489033000206585BAYER HEALTHCARE LLC, CONSUMER CARE1Y2026-01-0136 Columbia Rd MORRISTOWN NJ US 07960
19109531910953BAYER HEALTHCARE LLC1N2020-04-2512707 SHAWNEE MISSION PKWY Shawnee Mission KS US 66216

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
00616258003894XMI - XMI CUS CATHETER, FG PKG763-780-4555michael.burnside@bayer.com
00616258003924SOLENT OMNI - SOLENT OMNI CATHETER, FG PKG763-780-4555michael.burnside@bayer.com
00616258003955FETCH 2 - F2 CATHETER FG PKG763-780-4555michael.burnside@bayer.com
00616258005089SOLENT DISTA - SOLENT DISTA, FG PKG763-780-4555michael.burnside@bayer.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1887361802181199P020014ESSURE SYSTEMHHS2002-11-04
596651304371515K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH2015-12-22
596651460791089K052259DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406GEH2005-12-14
1887361463413124K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
596651671315556K031697DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226GEH2003-08-29
596651129076330
596651509386015
2008601509386015
596651657124756
596651749212935
596651917433349
596651932198061
1887362019301403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH22005-12-14
HHS22002-11-04
NUH12015-12-22
DXT12004-12-10

NDC#

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

AleveX

Bayer HealthCare LLC

camphor and menthol

AleveX

Bayer HealthCare LLC

camphor and menthol

AleveX

Bayer HealthCare LLC

camphor and menthol

200 records. Showing 1-40. Next

PMA#

PMN#

49 records. Showing 1-40. Next

Applications#

GUDID#

Dr. Scholl's - Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.

BAYER HEALTHCARE LLC

2016-09-01

Dr. Scholl's - Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.

BAYER HEALTHCARE LLC

2016-09-01

Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

BAYER HEALTHCARE LLC

2017-09-01

Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

BAYER HEALTHCARE LLC

2016-09-01

Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

BAYER HEALTHCARE LLC

2017-09-01

Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

BAYER HEALTHCARE LLC

2016-09-01