LXB

Product Code: LXB


Products Classified as LXB

1604Hearing Aid, Bone ConductionHearing Aid.

Total Product Life Cycle (TPLC) Devices

1604Hearing Aid, Bone ConductionHearing Aid.

FDA Consensus Standards

Hearing Aid, Bone Conduction [32695]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [32308]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [31251]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [38689]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [32302]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [29591]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [33856]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [38629]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [32305]21 CFR §874.3300 🔎
Hearing Aid, Bone Conduction [31252]21 CFR §874.3300 🔎

Pre-market Notifications for LXB

K213733Ponto 5 SuperPowerOticon Medical AB
K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas
K211640Ponto 5 MiniOticon Medical AB
K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppCochlear Americas
K190540Ponto 4Oticon Medical AB
K172460ADHEAR SystemMED-EL Elektromedizinische Geraete GmbH
K171088Cochlear Baha SoundArcCochlear Americas
K161671Ponto 3, Ponto 3 Power And Ponto 3 SuperPowerOTICON MEDICAL AB
K161123Baha 5 Power Sound ProcessorCochlear Americas
K153391Sophono Bone Conduction Systems (S) Configuration And (M) ConfigurationSOPHONO INC.
K153245Baha 5 Super Power Sound ProcessorCOCHLEAR AMERICAS
K150751Cordelle II Sound ProcessorCOCHLEAR AMERICAS
K142907Baha 5 Sound ProcessorCOCHLEAR AMERICAS
K132775PONTO PLUS AND PONTO PLUS POWEROTICON MEDICAL AB
K132278COCHLEAR BAHA 4 SOUND PROCESSORCOCHLEAR AMERICAS

Global Unique Device Identification Database

00643169841796Hearing aid, bone conduction
00643169799844Hearing aid, bone conduction
00643169799837Hearing aid, bone conduction
00643169799820Hearing aid, bone conduction
00643169719989Hearing aid, bone conduction
00643169719972Hearing aid, bone conduction
00643169719958Hearing aid, bone conduction
00643169719941Hearing aid, bone conduction
00643169719859Hearing aid, bone conduction
00643169719842Hearing aid, bone conduction
00643169719835Hearing aid, bone conduction
00643169719828Hearing aid, bone conduction
00643169719811Hearing aid, bone conduction
00643169719804Hearing aid, bone conduction
00643169719798Hearing aid, bone conduction

Maude Adverse Events

ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-31
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-31
BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURECOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-31
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-31
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-31
BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURECOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-30
BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURECOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-30
BIA300 IMPLANT 4MM W ABUTMENT 9MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
FLANGE FIXTURE ST 4MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
FLANGE FIXTURE ST 4MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BI300 IMPLANT 3MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BI300 IMPLANT 3MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-25
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-23
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-23
BIM400 IMPLANT MAGNETCOCHLEAR LTD2020-03-23
BIA400 IMPLANT 4MM W ABUTMENT 12MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-19
BIA400 IMPLANT 4MM W ABUTMENT 12MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-19
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-19
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-19
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-18
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-18
BIA300 IMPLANT 4MM W ABUTMENT 6MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-17
BI300 IMPLANT 4 MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-16
BI300 IMPLANT 4 MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-16
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-15
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-15
BI300 IMPLANT 3MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-12
BI300 IMPLANT 3MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-12
BIA300 IMPLANT 3MM W ABUTMENT 6MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-12
BIA300 IMPLANT 3MM W ABUTMENT 6MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-12
BAHA 5 SOUND PROCESSOR, BLACKCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-12
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-11
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BI300 IMPLANT 4 MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BI300 IMPLANT 4 MMCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
BIM400 IMPLANT MAGNETCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
ASKUCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-09
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