Valve, Prosthesis
Physical Medicine · 21 CFR 890.3420
Recent MDR events
11 adverse event reports on file
- QUICKVALVEJan 8, 2026InjuryOttobock Se & Co. Kgaa9616494-2026-00001
- OTTOBOCK HARMONY® P4 HD MECHANICAL PUMPApr 25, 2019InjuryOtto Bock Healthcare Lp1721652-2019-00002
- HARMONY® P3, SERVICE TEST CASEJul 19, 2016Otto Bock Healthcare Lp1721652-2016-00002
- ST. JUDE MEDICALAug 29, 1994InjurySt. Jude Medical, Inc.16740
- NIFeb 9, 1994InjuryCarpentier-edwards7472
- GASTROESOPHOGEAL ANTIREFLUX VALVE - ANGELCHIK PROSTHESISMay 17, 1993DeathUnknown5134
- 19 MM ST. JUDE PROTHESISMar 15, 1993MalfunctionSt. Jude Medical Inc.5377
- MEDTRONIC-HALLMar 15, 1993DeathMedtronic Inc.5408
- MITRAL VALVE PROSTHESISJan 6, 1993InjuryBjork-shiley2771
- GOTT-DAGGETT MITRAL VALVE PROSTHESIS/STARR-EDWARDSJul 13, 1992MalfunctionMedtronic3318
Event type breakdown
Registered firms
16 firms currently registered for this product code
Fillauer Europe
JARFALLA Stockholm, SE
Cypress Adaptive, Llc
Atlantic Highlands, NJ, US
Proteor Usa, Gunnison
Gunnison, UT, US
Otto Bock Healthcare Products Gmbh
Vienna Wien, AT
Willowwood Global Llc
Mt Sterling, OH, US
Fillauer, Llc
CHATTANOOGA, TN, US
O And P De Mexico S.a. De C.v.
Guadalajara Jalisco, MX
Ottobock Manufacturing Bulgaria Eood
Blagoevgrad, BG
Coyote O&p, Inc
Boise, ID, US
Amparo Prosthetics, Inc.
West Valley City, UT, US
Proteor Usa
Tempe, AZ, US
Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare Gmbh
DUDERSTADT Lower Saxony, DE
Cascade Orthopedic Supply, Lp.
Chico, CA, US
Proteor
Dijon Cedex Cote-d'Or, FR
Streifeneder Ortho.production Gmbh
EMMERING Bavaria, DE
Jaeger Medical Gmbh
HOECHBERG Bavaria, DE
510(k) clearances
1 clearances for this product code