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
00190776432256Millennium - Killian Struycken Nasal Speculum Right Blade: 45mm, Left 75mm1(877)289-1096product.questions@avalign.com
00190776432263Millennium - Antrum Curette, 70° Backward Angle, 3 x 6.5mm Cup, OL 7 1/2"1(877)289-1096product.questions@avalign.com
00190776432270Millennium - Antrum Curette, 70° Backward Angle, 4 x 6.5mm Cup, OL 7 1/2"1(877)289-1096product.questions@avalign.com
00190776432287Millennium - D-Reverse Hohmann Retractor 10 3/4" OL, 11mm width at the end1(877)289-1096product.questions@avalign.com
00190776432294Millennium - D-Glenoid Retractor 11"OL, 25mm wide blade1(877)289-1096product.questions@avalign.com
00190776432300Millennium - Keyfin Bipolar, 1.0mm tip, 11" Overall Length, Angled 20 Deg Down w/Fin Guide1(877)289-1096product.questions@avalign.com
00190776432317Millennium - Keyfin Bipolar, 1.2mm tip, 11" Overall Length, Angled 45 Deg Down, w/Fin Guide1(877)289-1096product.questions@avalign.com
00190776432324Millennium - Gerald Bipolar Forceps, Straight, Insulated, 1mm Straight Tip, 6 3/4", Stainless Steel1(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
1943301139446394K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemOVE2026-06-18
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
OVE12026-06-18
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