EWL — Prosthesis, Laryngeal (Taub)

21 CFR 874.3730

Class 2
Medical Specialty

EN

Review Panel

EN

Submission Type

1

FDA Authorisations (40)

Device Name K-Number
FirstFit Surgical Kit K240763
PROVOX FREEHANDS FLEXIVOICE K141380
PROVOX VEGA PUNCTURE SET K131947
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) K092593
BLOM-SINGER INDWELLING TEP OCCLUDER K093258
PROVOX VEGA, MODEL 8130-8135 K090455
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES K082206
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 K043138
PROVOX FREEHANDS HME, MODEL 7710 K022125
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS K991587
VOICE MASTER PROSTHESIS K974132
PROVOX 2 VOICE PROSTHESIS SYSTEM K971244
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE K945287
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE K945288
PROVOX(TM) VOICE PROSTHESIS K940638
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES K932120
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET K932163
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. K930105
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET K920090
SINGH SPEECH SYSTEM (SERIES 'SSS') K912486
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