Surgimedik Healthcare

FDA Filings

This page includes the latest FDA filings for Surgimedik Healthcare. 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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