2020년 10월 FDA 510(K) 승인 LIST

 

 

 

 

 

 

FDA 10월 510(K) 승인 발표 소식. 

 

주말과 겹쳐서 그런지 혹은 대선과 겹쳐서 그런지, 

지난 번 보다는 조금 늦은 시간에 났다. 

 

 

FDA 승인 리스트 살펴보기. 

 

그렇다면 이번 달에는 어떤 기업들이 승인이 났을까. 

FDA 에서는 이렇게 밝혔다. 

 

TOTAL 510(k)s THIS PERIOD 246

TOTAL WITH SUMMARIES 234

TOTAL WITH STATEMENTS 12

 

그렇다면 세부 LIST 는?

 

 

*출처 ; FDA 홈페이지. 

NAME	NO.
Hangzhou Minsheng Lide Medical Sci	NO: K181477
Arthrex Inc.	NO: K190707
Slow Wave, Inc.	NO: K191320
MedCAD	NO: K192282
Planmed Oy	NO: K192317
Brainlab AG	NO: K192703
C4 Imaging LLC	NO: K192771
Caldera Medical, Inc.	NO: K192811
Hemodia SAS	NO: K192921
Flower Orthopedics Corporation	NO: K192949
Maxx Orthopedics, Inc.	NO: K192989
SpineVision SAS	NO: K193000
Biomet Manufacturing Corp.	NO: K193038
Carefusion, Inc.	NO: K193088
Hocheng Corporation	NO: K193090
Nelson Environmental Technologies,	NO: K193169
Apex Medical Corp.	NO: K193206
eCordum, Inc.	NO: K193296
Inter-Med/ Vista Dental Products	NO: K193357
ImpediMed Limited	NO: K193410
BoxView, LLC	NO: K193421
BIOTRONIK, Inc	NO: K193474
Bellco Srl	NO: K193542
Triad Life Sciences, Inc.	NO: K193552
Precision BioLogic	NO: K193556
DIO Corporation	NO: K193623
M3DICINE Pty Ltd.	NO: K193631
Creo Medical Ltd.	NO: K200003
implantcast, GmbH	NO: K200045
Medacta International SA	NO: K200067
Zavation Medical Products LLC	NO: K200084
g.tec medical engineering GmbH	NO: K200088
3Shape A/S	NO: K200100
Bioteque Corporation	NO: K200103
Abiomed Inc.	NO: K200109
BioFilm Inc	NO: K200114
Erkodent Erich Kopp GmbH	NO: K200125
FH Industrie	NO: K200127
Medline Industries Inc	NO: K200150
GENOSS Co., Ltd.	NO: K200153
Genoss co.,Ltd.	NO: K200156
VBM Medizintechnik GmbH	NO: K200190
Carl Zeiss Meditec Cataract Techno	NO: K200207
Finemedix Co., Ltd.	NO: K200217
Pensar Medical, LLC	NO: K200223
Shenzhen Kentro Medical Electronic	NO: K200237
Kitazato Corporation	NO: K200249
DETAX GmbH & Co.KG	NO: K200273
Pegavision Corporation	NO: K200296
3M Company	NO: K200299
Medicrea International S.A.	NO: K200316
Karl Storz Endoscopy-America, Inc.	NO: K200318
Radformation, Inc.	NO: K200323
GM dos Reis Industria e Comercio L	NO: K200332
Z-Systems AG	NO: K200386
Shenzhen VitaVitro Biotech Co.,Ltd	NO: K200408
Mediana Co., Ltd.	NO: K200434
Wright Medical Technology, Inc.	NO: K200507
Vyaire Medical, Inc.	NO: K200510
Diamond Diagnostics Inc.	NO: K200544
CellaVision AB	NO: K200595
Icotec AG	NO: K200596
Sk bioland Co., Ltd.	NO: K200623
GC America Inc.	NO: K200682
Arthrosurface, Inc.	NO: K200718
Acuitive Technologies	NO: K200725
S H Pitkar Orthotools Pvt Ltd.	NO: K200728
DeRoyal Industries, Inc.	NO: K200757
Medtronic Xomed, Inc.	NO: K200759
Centrix Incorporated	NO: K200764
EnzySurge Ltd.	NO: K200767
Medacta Inernational SA	NO: K200792
Shenzhen Urion Technology Co., Ltd	NO: K200802
Nobel Biocare AB	NO: K200810
TruAbutment Inc.	NO: K200817
Medentika GmbH	NO: K200906
Indius Medical Technologies Pvt. L	NO: K200937
NuVasive, Incorporated	NO: K200953
Luce Castle Co., Ltd.	NO: K201038
Imaging Biometrics, LLC	NO: K201092
Medline Industires, Inc.	NO: K201129
Foosin Medical Supplies Inc., Ltd.	NO: K201139
CareFusion	NO: K201155
Bioland Technology Ltd.	NO: K201161
Plexus Optix, Inc.	NO: K201268
Scopio Labs LTD.	NO: K201301
Everyway Medical Instruments Co.,	NO: K201335
Xinkang Medical Instrument Co., Lt	NO: K201359
Cordis Corporation	NO: K201377
Philips Consumer Lifestyle - Innov	NO: K201381
Stryker ENT	NO: K201398
West Pharmaceutical Services AZ, I	NO: K201415
Benvenue Medical, Inc.	NO: K201427
Edwards Lifesiences, LLC	NO: K201446
Paradigm Spine, GmbH	NO: K201453
CAO Group, Inc.	NO: K201475
Zhengzhou Huaer Electro Optics Tec	NO: K201483
Pioneer Surgical Technology, Inc.	NO: K201497
Apple Inc.	NO: K201525
InnoCare Optoelectronics Corp.	NO: K201528
BoneSupport AB	NO: K201535
RevisiOs BV	NO: K201546
Cyberdyne Inc.	NO: K201559
Neoss Limited	NO: K201561
Vitalograph Ireland Ltd.	NO: K201562
Embody, Inc.	NO: K201572
Icotec AG	NO: K201587
Merit Medical Systems, Inc.	NO: K201595
Abbott Medical	NO: K201610
GE Medical Systems, LLC	NO: K201615
Vatech Co., Ltd	NO: K201627
S.M.A.I.O	NO: K201659
Siemens Medical Solutions USA, Inc	NO: K201670
S.I.N. - Sistema de Implante Nacio	NO: K201688
NuVasive, Incorporated	NO: K201692
Medical Ingenuities	NO: K201695
Smith & Nephew, Inc.	NO: K201701
Coreline Soft Co., Ltd.	NO: K201710
OCULUS Optikgerate GmbH	NO: K201724
GE Healthcare	NO: K201768
LG Electronics Inc.	NO: K201777
Ossio Ltd.	NO: K201803
Reflow Medical, Inc.	NO: K201811
Accuro Technologies Inc.	NO: K201816
Theranica Bio-Electronics LTD.	NO: K201824
GE Medical Systems Ultrasound and	NO: K201828
Wenzhou Yosun Medical Technology C	NO: K201843
Guangzhou Longest Science & Techno	NO: K201845
Lexington Medical Inc.	NO: K201882
Microline Surgical, Inc.	NO: K201884
CarboFix Orthopedics, Ltd.	NO: K201917
PrinterPrezz	NO: K201939
Skeletal Dynamics, Inc.	NO: K201962
Schoelly Fiberoptic GmbH	NO: K201970
Canon Medical Systems Corporation	NO: K201972
Med-El Elektromedizinische Geraete	NO: K201983
Sonoscanner	NO: K201988
Better Health Medical Products Co.	NO: K202010
Whiterabbit.ai Inc.	NO: K202013
Howmedica Osteonics Corp., dba Str	NO: K202016
Hitachi Healthcare Americas	NO: K202030
Quanta System SpA	NO: K202041
Hanuri Distribution, Inc	NO: K202044
Astura Medical, LLC	NO: K202065
Orthophor, LLC	NO: K202071
Neocis Inc.	NO: K202100
OsteoMed LLC	NO: K202105
Respironics, Inc.	NO: K202142
Medacta International SA	NO: K202152
Smith & Nephew Medical Limited	NO: K202157
Perspectum LTD	NO: K202170
Medline Industries, Inc.	NO: K202179
Neurostructures	NO: K202190
Materialise NV	NO: K202207
Siemens Medical Solutions USA, Inc	NO: K202213
Boston Scientific Corporation	NO: K202218
Genesee BioMedical, Inc	NO: K202253
Parcus Medical, LLC	NO: K202259
Cleerly, Inc.	NO: K202280
Medline Industries, Inc.	NO: K202285
EBM Technologies Inc.	NO: K202292
Atlas Spine, Inc.	NO: K202302
Zavation Medical Products, LLC	NO: K202305
Zimmer Biomet Spine, Inc.	NO: K202309
Alphatec Spine, Inc.	NO: K202327
HTL-Strefa S.A.	NO: K202340
Canon Medical Systems Corporation	NO: K202349
Three Circles Consulting Limited	NO: K202357
Canon Medical Systems Corporation	NO: K202364
Shenzhen Beacon Display Technology	NO: K202374
Sirtex Medical US Holdings Inc.	NO: K202392
Stryker Corporation	NO: K202393
b-One Ortho, Corp.	NO: K202429
SMART Medical Systems Ltd.	NO: K202469
Advanced Orthopaedic Solutions, In	NO: K202489
Globus Medical Inc.	NO: K202496
Taiwan Aulisa Medical Devices Tech	NO: K202497
Quantib BV	NO: K202501
Orthofix Srl	NO: K202519
K2M Inc.	NO: K202528
Applied Medical Technology, Inc.	NO: K202539
Samsung Medison Co., LTD	NO: K202556
Howmedica Osteonics Corp aka Stryk	NO: K203099