MVA

Product Code: MVA


Products Classified as MVA

3742Orthosis, CranialCranial Orthosis.

Total Product Life Cycle (TPLC) Devices

3742Orthosis, CranialCranial Orthosis.

Pre-market Notifications for MVA

K220681Talee, Talee PostOPInvent Medical USA, LLC
K213587MyCRO BandOtto Bock Healthcare LP
K203134Hanger Cranial Band 3DSymbion Logistics, LLC
K201426MyCRO BandOtto Bock Healthcare LP
K180568KidCapEastern Cranial Affiliates, LLC
K141842STARBAND, STARLIGHTORTHOMERICA PRODUCTS, INC.
K140353STARBAND AND STARLIGHTORTHOMERICA PRODUCTS, INC.
K133397P-PODP-POD
K111609BOSTON BANDBOSTON BRACE INTL., INC.
K111247CRANIAL REMOLDING ORTHOSISORTHOTIC CARE SERVICES, LLP
K103362AOI CRANIAL HELMETADVANCED ORTHOPRO INC.
K090341MICHIGAN CRANIAL RESHAPING ORTHOSISDANMAR PRODUCTS, INC.
K063395O&P BIVALVE CRANIAL MOLDING HELMETORTHOTIC & PROSTHETIC LAB, INC.
K063133CRANIAL SOLUTION ORTHOSISCRANIAL SOLUTIONS
K042385DOC BAND-POSTOPCRANIAL TECHNOLOGIES, INC.

Global Unique Device Identification Database

00863457000302Orthosis, Cranial
00859065006003Orthosis, Cranial
B288CRANIALHELMET0Orthosis, Cranial
B151764PA0Orthosis, Cranial
B151764A0Orthosis, Cranial
B15176407PA0Orthosis, Cranial
B15176406PA0Orthosis, Cranial
B15176406A0Orthosis, Cranial
B15176403PA0Orthosis, Cranial
B15176403A0Orthosis, Cranial
B15176401PA0Orthosis, Cranial
B15176401A0Orthosis, Cranial
B15176308PA0Orthosis, Cranial
B151762PA0Orthosis, Cranial
B151762A0Orthosis, Cranial

Maude Adverse Events

LYOPLANT ONLAY 7.5X7.5CMAESCULAP AG2017-10-12
LYOPLANT ONLAY 10.0X12.5CMAESCULAP AG2017-10-12
CRANIAL PERFORATOR 9/12MM HUDSON SHANKAESCULAP AG2017-05-15
CRANIAL REMOLDING HELMETKINDERBAND2016-06-14
DOC CRANIAL BANDING HELMETCRANIAL TECHNOLOGIES2015-06-02
P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSISPERSONAL PERFORMANCE MEDICAL CORP.2010-09-22
CRANIAL ORTHOTIC STARBAND HELMETORTHOMERICA2010-09-01
STRYKER CUSTOM CRANIAL IMPLANT KIT - MEDIUM2009-01-09
STRYKER CUSTOM CRANIAL IMPLANT KITSTRYKER2008-11-03
STRYKER CUSTOM CRANIAL IMPLANT KITSTRYKER2008-11-03
STRYKER CUSTOM CRANIAL IMPLANT KITSTRKER2008-11-03
HANGER CRANIAL HELMETHANGER2006-02-27
STARSCANNERORTHOAMERICA2006-02-25
CRANIAL HELMETBALLERT ORTHOPEDIC OF CHICAGO2000-03-30
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