Galaxy India

FDA Filings

This page includes the latest FDA filings for Galaxy India. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015223105
FEI Number3015223105
NameGALAXY INDIA
Owner & OperatorGALAXY INDIA
Contact AddressT-5/237, MANGOLPURI INDL. AREA, PHASE-1
NEW DELHI IN-DL Delhi 110083 IN
Official Correspondent
  • SATYA SHEEL GUPTA
  • 91-999-9926655-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressT-5/237, MANGOLPURI INDL. AREA, PHASE-1
NEW DELHI Delhi, 110083 IN
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
GALAXY INDIA
KIARA 6M WITH BATTERY BACK-UP, ALINA 12M, ALINA 12M WITH BATTERY BACK-UP, ALINA 9M, ALINA 9M WITH BATTERY BACK-UP2019-02-19
GALAXY INDIA
KIARA 12M, KIARA 12M WITH BATTERY BACK-UP, KIARA 9M, KIARA 9M WITH BATTERY BACK-UP, KIARA 6M,2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Examination Light Mobile2019-02-19
GALAXY INDIA
ALINA 6M, ALINA 6M WITH BATTERY BACK-UP2019-02-19
GALAXY INDIA
GI 101, GI 102, GI 103, GI 104, GI 1052019-02-19
GALAXY INDIA
GALAXY INDIA Bed Side Cabinet2019-02-19
GALAXY INDIA
STEINMANN PIN HOLDING CLAMP, SHOULDER SURGERY ATTACHMENT, BACK-BUTTOCKS SUPPORT, PUBIS-SACRUM-STERNUM SUPPORT2019-02-19
GALAXY INDIA
SPINAL FRAME, MAYFIELD 3 PIN SKULL CLAMP, SUGITA 4 PIN SKULL CLAMP, LEYLA RETRACTOR SYSTEM, HORSESHOE HEADREST2019-02-19
GALAXY INDIA
RELAX, RELAX ADVANCE, RELIEF, RELIEF ADVANCE, SURGICAL TABLE ACCESSORIES, LEG TRACTION DEVICE, HAND TRACTION DEVICE,2019-02-19
GALAXY INDIA
POPLITEAL SUPPORT, TIBIA SUPPORT, HIP NAILING SUPPORT, RADIO-TRANSLUCENT HAND OPERATING TABLE,2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Operating Table Manual with Orthopedic Accessories2019-02-19
GALAXY INDIA
ARTHROSCOPY POSITIONING DEVICE, KNEE CHEST POSITIONING DEVICE, LATERAL ARMREST, SPINAL BRIDGE WILSON2019-02-19
GALAXY INDIA
SURGICAL TABLE ACCESSORIES, LEG TRACTION DEVICE, HAND TRACTION DEVICE, POPLITEAL SUPPORT, TIBIA SUPPORT2019-02-19
GALAXY INDIA
STYLA,STYLA ADVANCE, STYLA PRO, AURA, AURA ADVANCE, AURA PRO2019-02-19
GALAXY INDIA
LEYLA RETRACTOR SYSTEM, HORSESHOE HEADREST2019-02-19
GALAXY INDIA
LATERAL ARMREST, SPINAL BRIDGE WILSON, SPINAL FRAME, MAYFIELD 3 PIN SKULL CLAMP, SUGITA 4 PIN SKULL CLAMP2019-02-19
GALAXY INDIA
HIP NAILING SUPPORT, RADIO-TRANSLUCENT HAND OPERATING TABLE, STEINMANN PIN HOLDING CLAMP, SHOULDER SURGERY ATTACHMENT2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Operating Table AC Powered with Orthopedic Accessories2019-02-19
GALAXY INDIA
ECOLINE, ECOLINE ADVANCE, ECOLINE PRO, ECOLINE-SL, ECOLINE-SL ADVANCE, ECOLINE-SL PRO2019-02-19
GALAXY INDIA
BACK-BUTTOCKS SUPPORT, PUBIS-SACRUM-STERNUM SUPPORT, ARTHROSCOPY POSITIONING DEVICE, KNEE CHEST POSITIONING DEVICE,2019-02-19
GALAXY INDIA
AZURE-SL PRO, AZURE-BR, AZURE-BR ADVANCE, AZURE-BR PRO, AZURE-ESWL2019-02-19
GALAXY INDIA
AZURE-ESWL ADVANCE, AZURE-ESWL PRO, AURIS, AURIS ADVANCE, AURIS ADVANCE PLUS, AURIS PRO, AURIS-SL, AURIS-SL ADVANCE2019-02-19
GALAXY INDIA
AURIS-SL PRO, AURIS-BR, AURIS-BR ADVANCE, AURIS-BR PRO,ACURA, ACURA ADVANCE, ACURA ADVANCE PLUS2019-02-19
GALAXY INDIA
ASIRA-ESWL, ASIRA-ESWL ADVANCE, ASIRA-ESWL PRO, AZURE, AZURE ADVANCE, AZURE PRO, AZURE-SL, AZURE-SL ADVANCE2019-02-19
GALAXY INDIA
ASIRA, ASIRA ADVANCE, ASIRA PRO, ASIRA-SL, ASIRA-SL ADVANCE, ASIRA-SL PRO, ASIRA-BR, ASIRA-BR ADVANCE, ASIRA-BR PRO,2019-02-19
GALAXY INDIA
ACURA PRO, ACURA-SL, ACURA-SL ADVANCE, ACURA-SL PRO, ACURA-BR, ACURA-BR ADVANCE, ACURA-BR PRO2019-02-19
GALAXY INDIA
LED X-RAY FILM VIEWER BACK LIT MODELS: XB1, XB2, XB3, XB4, LED X-RAY FILM VIEWER SIDE LIT MODELS: XS1, XS2, XS3, XS42019-02-19
GALAXY INDIA
GALAXY INDIA LED X-Ray Film Viewer2019-02-19
GALAXY INDIA
SURGICAL TABLE ACCESSORIES FOR GENERAL SURGERY, ENT, GYNAECOLOGY, UROLOGY, ORTHOPAEDICS, TRUMATOLOGY2019-02-19
GALAXY INDIA
STYLA ADVANCE, STYLA PRO, AURA, AURA ADVANCE, AURA PRO2019-02-19
GALAXY INDIA
SPINAL SURGERY, NEUROSURGERY, GAS SPRING ASSISTED POWER STIRRUPS2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Operating Table Electric2019-02-19
GALAXY INDIA
ECOLINE PRO, ECOLINE-SL, ECOLINE-SL ADVANCE, ECOLINE-SL PRO, STYLA,2019-02-19
GALAXY INDIA
AZURE-SL ADVANCE, AZURE-SL PRO,AZURE-BR, AZURE-BR ADVANCE, AZURE-BR PRO, AZURE-ESWL, AZURE-ESWL ADVANCE, AZURE-ESWL PRO,2019-02-19
GALAXY INDIA
AURIS-BR ADVANCE, AURIS-BR PRO,ACURA, ACURA ADVANCE, ACURA ADVANCE PLUS, ACURA PRO, ACURA-SL2019-02-19
GALAXY INDIA
AURIS, AURIS ADVANCE, AURIS ADVANCE PLUS, AURIS PRO, AURIS-SL, AURIS-SL ADVANCE, AURIS-SL PRO, AURIS-BR,2019-02-19
GALAXY INDIA
ASIRA-BR PRO, ASIRA-ESWL, ASIRA-ESWL ADVANCE, ASIRA-ESWL PRO, AZURE, AZURE ADVANCE, AZURE PRO, AZURE-SL,2019-02-19
GALAXY INDIA
ASIRA, ASIRA ADVANCE, ASIRA PRO, ASIRA-SL, ASIRA-SL ADVANCE, ASIRA-SL PRO, ASIRA-BR, ASIRA-BR ADVANCE2019-02-19
GALAXY INDIA
ACURA-SL ADVANCE, ACURA-SL PRO, ACURA-BR, ACURA-BR ADVANCE, ACURA-BR PRO, ECOLINE, ECOLINE ADVANCE2019-02-19
GALAXY INDIA
KIARA 700/700/700, KIARA 700/700/700 WITH CAMERA AND MONITOR,KIARA 700/700/500,KIARA 700/700/500 WITH CAMERA AND MONITOR2019-02-19
GALAXY INDIA
KIARA 700/700, KIARA 700/700 WITH CAMERA AND MONITOR, KIARA 700/500, KIARA 700/500 WITH CAMERA AND MONITOR2019-02-19
GALAXY INDIA
KIARA 500/500, KIARA 500/500 WITH CAMERA AND MONITOR, KIARA 700, KIARA 600, KIARA 500, KIARA 3002019-02-19
GALAXY INDIA
KIARA 12, KIARA 9, ALINA 5+5+5, ALINA 5+5+5 WITH CAMERA AND MONITOR, ALINA 5+5+3, ALINA 5+5+3 WITH CAMERA AND MONITOR2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Shadowless Operating Light Ceiling Mounted2019-02-19
GALAXY INDIA
ALINA 5+5, ALINA 5+5 WITH CAMERA AND MONITOR, ALINA 5+4, ALINA 5+4 WITH CAMERA AND MONITOR2019-02-19
GALAXY INDIA
ALINA 5+3, ALINA 5+3 WITH CAMERA AND MONITOR, ALINA 4+3, ALINA 4+3 WITH CAMERA AND MONITOR ALINA 3+32019-02-19
GALAXY INDIA
ALINA 3+3 WITH CAMERA AND MONITOR, ALINA 5, ALINA 4, ALINA 3, ALINA 12, ALINA 92019-02-19
GALAXY INDIA
KIARA 700M, KIARA 700M WITH BATTERY BACK-UP, KIARA 600M, KIARA 600M WITH BATTERY BACK-UP, KIARA 500M,2019-02-19
GALAXY INDIA
KIARA 500M WITH BATTERY BACK-UP, KIARA 300M, KIARA 300M WITH BATTERY BACK-UP, ALINA 5M,ALINA 5M WITH BATTERY BACK-UP2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Shadowless Operating Light Mobile2019-02-19
GALAXY INDIA
ALINA 4M, ALINA 4M WITH BATTERY BACK-UP, ALINA 3M, ALINA 3M WITH BATTERY BACK-UP2019-02-19
GALAXY INDIA
RELAX, RELAX ADVANCE, RELIEF, RELIEF ADVANCE, SURGICAL TABLE ACCESSORIES FOR GENERAL SURGERY2019-02-19
GALAXY INDIA
GALAXY INDIA Surgical Operating Table Manual2019-02-19
GALAXY INDIA
ENT, GYNAECOLOGY, UROLOGY, ORTHOPAEDICS, TRUMATOLOGY, SPINAL SURGERY, NEUROSURGERY, GAS SPRING ASSISTED POWER STIRRUPS2019-02-19
GALAXY INDIA
GI 501, GI 502, GI 503, GI 504, GI 5052019-02-19
GALAXY INDIA
GALAXY INDIA Stretcher Trolley2019-02-19
GALAXY INDIA
SEMI FOWLER BED MODELS: GI 1100, GI 2100, DELIVERY BED MODELS: GI 555, GI 666, GI 777, WHEEL CHAIR2019-02-19
GALAXY INDIA
ICU BED MODELS: GI 5100, GI 6100, GI 7100, GI 8100, FOWLER BED MODELS: GI 3100, GI 4100,2019-02-19
GALAXY INDIA
GALAXY INDIA Hospital Bed AC Powered2019-02-19
GALAXY INDIA
SEMI FOWLER BED MODELS: GI 1000, GI 2000, DELIVERY BED MODELS: GI 111, GI 222, GI 333, WHEEL CHAIR2019-02-19
GALAXY INDIA
ICU BED MODELS: GI 5000, GI 6000, GI 7000, GI 8000, FOWLER BED MODELS: GI 3000, GI 40002019-02-19
GALAXY INDIA
GALAXY INDIA Hospital Bed Manual2019-02-19
GALAXY INDIA
SACRAL PROTECTOR GEL, CONTOURED ARM REST GEL, FLAT ARM REST GEL, KNEE PAD GEL, CONTOURED LEG REST GEL, CRUTCH PAD GEL2019-02-19
GALAXY INDIA
OPEN HEAD RING GEL, CLOSED HEAD RING GEL, HORSESHOE HEAD RING GEL, OPTHALMIC HEAD REST GEL, PRONE POSITION HEAD REST GEL2019-02-19
GALAXY INDIA
MINI HEAD BASE RING GEL, MINI HORSESHOE HEAD RING GEL, NEONATAL ROLL GEL, NEONATAL HEAD CRADLE GEL2019-02-19
GALAXY INDIA
HEEL SUPPORT GEL, UNIVERSAL GEL PAD, UNIVERSAL OPERATING TABLE GEL PAD, PRONE POSITION GEL BED, FLAT PRONE GEL BED2019-02-19
GALAXY INDIA
GALAXY INDIA Patient Positioning Gel Pads2019-02-19
GALAXY INDIA
DOME POSITIONER GEL, UNIVERSAL POSITIONER GEL, FLAT BOTTOM CHEST ROLL GEL, LATERAL POSITIONER GEL, ELBOW PROTECTOR GEL2019-02-19
GALAXY INDIA
SURGICAL TABLE ACCESSORIES FOR GENERAL SURGERY, ENT, GYNAECOLOGY, UROLOGY, ORTHOPAEDICS, TRUMATOLOGY2019-02-14
GALAXY INDIA
SPINAL SURGERY, NEUROSURGERY, GAS SPRING ASSISTED POWER STIRRUPS2019-02-14
GALAXY INDIA
GALAXY INDIA Surgical Operating Table AC Powered2019-02-14
GALAXY INDIA
AZURE-SL ADVANCE, AZURE-SL PRO,AZURE-BR, AZURE-BR ADVANCE, AZURE-BR PRO, AZURE-ESWL, AZURE-ESWL ADVANCE, AZURE-ESWL PRO,2019-02-14
GALAXY INDIA
AURIS-BR ADVANCE, AURIS-BR PRO,STYLA ADVANCE, STYLA PRO, AURA, AURA ADVANCE, AURA PRO,2019-02-14
GALAXY INDIA
AURIS, AURIS ADVANCE, AURIS ADVANCE PLUS, AURIS PRO, AURIS-SL, AURIS-SL ADVANCE, AURIS-SL PRO, AURIS-BR,2019-02-14
GALAXY INDIA
ASIRA-BR PRO, ASIRA-ESWL, ASIRA-ESWL ADVANCE, ASIRA-ESWL PRO, AZURE, AZURE ADVANCE, AZURE PRO, AZURE-SL,2019-02-14
GALAXY INDIA
ASIRA, ASIRA ADVANCE, ASIRA PRO, ASIRA-SL, ASIRA-SL ADVANCE, ASIRA-SL PRO, ASIRA-BR, ASIRA-BR ADVANCE2019-02-14
GALAXY INDIA
ACURA-BR PRO, ECOLINE, ECOLINE ADVANCE, ECOLINE PRO, ECOLINE-SL, ECOLINE-SL ADVANCE, ECOLINE-SL PRO, STYLA2019-02-14
GALAXY INDIA
ACURA, ACURA ADVANCE, ACURA ADVANCE PLUS, ACURA PRO,ACURA-SL, ACURA-SL ADVANCE, ACURA-SL PRO, ACURA-BR,ACURA-BR ADVANCE2019-02-14

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