Olympus Surgical Technologies America

FDA Filings

This page includes the latest FDA filings for Olympus Surgical Technologies America. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Olympus Surgical Technologies America holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9611174
FEI Number1000162602
NameKEYMED (Medical & Industrial Equipment) Ltd
Owner & OperatorOlympus Surgical Technologies America
Contact Address136 Turnpike Road
Southborough MA 01772 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressKeyMed House Stock Road
SOUTHEND-ON-SEA Essex, SS2 5QH GB
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



Registration Number3007389669
FEI Number3007389669
NameAlgram Group Ltd
Owner & OperatorOlympus Surgical Technologies America
Contact Address136 Turnpike Road
Southborough MA 01772 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressEastern Wood Road Langage Industrial Estate, Plympton
Plymouth Devon, PL7 5ET GB
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Olympus Surgical Technologies America
ViziShot 2 FLEX2020-03-18
Olympus Surgical Technologies America
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, And Accessories)2019-08-09
Olympus Surgical Technologies America
CleverLock Guidewire Locking Device And Biopsy Cap2019-04-04
Olympus Surgical Technologies America
PeriView FLEX2018-07-03
Olympus Surgical Technologies America
PeriView FLEX2017-09-21
Olympus Surgical Technologies America
ViziShot 2 FLEX2017-04-06
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
Sigmoidoscope Suction Pump2016-09-13
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
Sterilization case and accessories2015-12-04
Algram Group Ltd [Olympus Surgical Technologies America]
Sterilization case and accessories2015-12-04
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
KV-62015-06-08
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
KV-62015-06-08
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter2015-03-27
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER2013-10-21
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
VARI-PASS VARIABLE LENGTH ACCESS SHEATH2013-02-04
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
MAJ-172 Sterilization Tray for Endoscopes2013-01-11
Algram Group Ltd [Olympus Surgical Technologies America]
MAJ-172 Sterilization Tray for Endoscopes2013-01-11
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
GYRUS ACMI BICOAG HEMOSTASIS PROBE2012-12-14
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
OFP-2 (OLYMPUS FLUSHING PUMP)2012-03-05
Algram Group Ltd [Olympus Surgical Technologies America]
OFP-2 (OLYMPUS FLUSHING PUMP)2012-03-05
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
WM-*P2 series of endoscopy workstations2011-01-13
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
WM-*P1 series of endoscopy workstations2011-01-13
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
TC series of endoscopy workstations2011-01-13
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
KV-5 Suction Pump & Accesories2008-01-23
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
OFP (Olympus Flushing Pump)2008-01-23
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
MAJ-178 STERILISATION TRAY2006-05-12
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
MAJ-178 BRONCHOSCOPE TRAY2006-05-12
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
ENDOSCOPE MOUTHPIECE2004-10-06
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
ENDOSCOPE MOUTHGUARD2004-10-06
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
ENDOSCOPE BITE BLOCK2004-10-06
Algram Group Ltd [Olympus Surgical Technologies America]
ENDOSCOPE MOUTHPIECE2004-10-06
Algram Group Ltd [Olympus Surgical Technologies America]
ENDOSCOPE MOUTHGUARD2004-10-06
Algram Group Ltd [Olympus Surgical Technologies America]
ENDOSCOPE BITE BLOCK2004-10-06
KEYMED (Medical & Industrial Equipment) Ltd [Olympus Surgical Technologies America]
ENDOSONIC1982-12-08

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