FDA.reportPublic FDA data

AVALIGN TECHNOLOGIES, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088646033008864603AVALIGN TECHNOLOGIES, Inc.1N2026-01-018727 Clinton Park Dr Fort Wayne IN US 46825

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00190776300524Millennium - Universal Fiberoptic Cable Olympus Retractable+1(877)289-1096product.questions@avalign.com
00190776300531Millennium - Rectal Fiberoptic Light Attachment+1(877)289-1096product.questions@avalign.com
00190776301576Millennium - FO Light carrier wPilling connection for Jesberg Oval Esophagoscope+1(877)289-1096product.questions@avalign.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1943301905673836K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
1943301135149702K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemOVD2025-07-10
1943301112063166K193066Steripack cases and Tray SystemsKCT2020-08-06
1943301952665183K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP2010-08-31
1943301993360716K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXHDA2010-04-29
1943301557001192K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZ2009-12-03
1943301012492812K092544INSTRUMED VASCULAR CLAMPSDXC2009-10-26
1943301605293233K081651INSTRUMED RONGEURHAE2008-08-08
1943301922484621K071771INSTRUMED RETRACTORSGZT2007-08-02
1943301899199344K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEI2004-04-16
1943301066125290
1943301277196678
1943301441906075
1943301611935813
1943301005061186
1943301059611042
1943301076498096
1943301114907768
1943301154681019
1943301157551798
1943301189034039
1943301326755067
1943301341034369
1943301362210319
1943301376896428
1943301433400479
1943301462648822
1943301483770129
1943301496961371
1943301570314304
1943301601874367
1943301608877739
1943301800152382
1943301878810269
1943301905590942
1943301905755920
1943301992345778

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KCT22020-08-06
OVD12025-07-10
DWP12010-08-31
HDA12010-04-29
HCZ12009-12-03
DXC12009-10-26
HAE12008-08-08
GZT12007-08-02
GEI12004-04-16

PMN#

GUDID#

200 records. Showing 1-40. Next