Surgimedik Healthcare India Pvt L T D

FDA Filings

This page includes the latest FDA filings for Surgimedik Healthcare India Pvt L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9617744
FEI Number3006279007
NameSURGIMEDIK HEALTHCARE
Owner & OperatorSURGIMEDIK HEALTHCARE INDIA PVT. LTD.
Contact Address53-CD, KANDIVALI INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W)
MUMBAI, MAHARASTRA IN-NOTA 400 104 IN
Official Correspondent
  • DHIREN - MEHTA
  • 91-22-28609401-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSURGIMEDIK House, Plot No. 223 Surat Special Economic Zone, Sachin
Surat Gujarat, 394230 IN
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter with Malleable Stylet2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Shorty2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Duo2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Curved2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter with Malleable Stylet2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Shorty2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Duo2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Intra Uterine Insemination Catheter Curved2020-04-02
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
OPICK Double Lumen Ovum Pick Up Needle2020-03-27
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Eagle-M Manual Single Lumen Ovum Pick Up Needle2020-03-27
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Eagle-FL Single Lumen Ovum Pick Up Needle with Flushing Line2020-03-27
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Eagle Single Lumen Ovum Pick-up Needle2020-03-27
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Bite-O-Bite Block2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
MECHLITH - Mechanical Lithotripter2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Meatal Dilator - Pediatric2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Meatal Dilator - Adult2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Urine Bag Connector2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Stent Remover Snare2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Pull It Stent Remover2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Ureteral Dilator Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Renal Dilator2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Renal Dilator With Amplatz Sheath2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
NOTTINGHAM One Step Dilator2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Fascial Dilator Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Amplatz Sheath2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Amplatz Renal Dilator Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
ULTIMA Direct Puncture Drainage Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Re-Entry Malecot Catheter2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Drainage Set - ULTIMA2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Drainage Set - Pigtail2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Drainage Set - Malecot2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Catheter - ULTIMA2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Catheter - Pigtail2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Percutaneous Nephrostomy Catheter - Malecot2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
SURGI BAND - Multiple Ligator2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
SURGI BAND - Multiple Ligator Kit2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Contistrap Male Incontinence Clamp2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
TRACKFINDER Bulb Irrigator2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
ASEPTO Bulb Irrigation Syringe2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Suprapubic Puncture and Drainage Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Suprapubic Metal Tip Puncture and Drainage Set2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Standard - Straight Tip Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Standard - J Tip Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Schuller Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
SUPREMO - Nitinol Hydrophilic Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Lunderquist Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
King Cobra - Hydrophilic Nitinol Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
HYGUIDE Hydrophilic Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Cobra - Nitinol Guidewire2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Ultracore Biopsy Needle - Manual2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
SPEEDO Biopsy Needle2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
PRONTO Semi-Auto Biopsy Needle With Coax Needle2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Auto Core Biopsy Needle2018-09-11
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Stent Remover2009-02-27
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Ultracore Biopsy Needles2008-06-20
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Autocore Biopsy needles2008-06-20
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
BREAST LOCALIZATION NEEDLE2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
TUR-VAC Bladder Evacuator2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
Ellick Bladder Evacuator - Plastic2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
ELLIK BLADDER EVACUATOR2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
ELLICK Bladder Evacuator - Glass2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
CATHETER FIXING DISK2007-07-31
SURGIMEDIK HEALTHCARE [SURGIMEDIK HEALTHCARE INDIA PVT. LTD.]
STONE BASKET2007-07-31

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