Gyrus Medical L T D

FDA Filings

This page includes the latest FDA filings for Gyrus Medical 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 Number9617070
FEI Number3002807134
NameGYRUS MEDICAL LTD.
Owner & OperatorOlympus Winter & Ibe GmbH
Contact AddressKUEHNSTRASSE 61 --
HAMBURG DE-NOTA 22045 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFORTRAN RD., ST. MELLONS
CARDIFF Wales, CF3 0LT GB
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Electrosurgical Generator ESG-1502018-11-30
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Pressure Reducer2018-04-27
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
MAPC Probes2018-04-27
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ESG-3002018-04-27
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
APU-3002018-04-27
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK PLASMA-V INSTRUMENT2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK PLASMA-V INSTRUMENT2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE LOW PROFILE SUCTION (LPS) ELECTRODE ONE PIECE S50 PLUS ELECTRODE2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE2017-01-23
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
HYSTEROSCOPIC BRIDGE (VISUAL OBTURATOR) ROTATABLE OUTER SHEATH2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SHORT SIDE ELECTRODE (2.3 VAPR SIDE EFFECT (SHORT))2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SHORT SIDE ELECTRODE (2.3 VAPR SIDE EFFECT (SHORT))2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD END ELECTRODE (2.3 VAPR END EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
WORKING ELEMENT PASSIVE (RESECTOSCOPE WORKING ELEMENT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
TELESCOPE WA 4mm 30 DEG (HYSTEROSCOPE 4.0mm 30 DEG ? WIDE ANGLE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
TELESCOPE 4mm 12 DEG HIGH MAGNIFICATION (HYSTEROSCOPE 4.0mm 12 DEG ? HM)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
STANDARD OBTURATOR (RESECTOSCOPE OBTURATOR ? STANDARD)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
OUTER SHEATH (RESECTOSCOPE SHEATH, OUTER ? STANDARD2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
INNER SHEATH (RESECTOSCOPE SHEATH, INNER ? 24 Fr.2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GYNECARE ? HYSTEROSCOPIC SYSTEM : RESECTOSCOPE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPRFLEX SIDE EFFECT (FLEX SIDE EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPRFLEX END EFFECT (FLEX END EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
THERMAL REV ANGLED SIDE (VAPR T THERMAL REV ANGLED SIDE)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
THERMAL ANGLED END (VAPR T THERMAL ANGLED END)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
THERMAFLEX SIDE EFFECT (FLEX THERMAL SIDE EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
THERMAFLEX END EFFECT (FLEX THERMAL END EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD STANDARD WEDGE 2.3mm WEDGE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SHORT WEDGE (2.3mm WEDGE (SHORT))2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VERSAPOINT GENERATOR2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
TWIZZLE ELECTRODE (5 PACK)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
SPRING ELECTRODE (5 PACK)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
FOOTSWITCH (SMALL)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
BALL ELECTRODE (5 PACK)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR Tripolar 90 Suction electrode2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR COOLPULSE Curve Suction Electrode2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR COOLPULSE Curve Suction Electrode XL2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR ARCTIC articulating hip electrode with dome tip2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR ARCTIC articulating hip electrode with chisel tip2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE SMALL DIAMETER SUCTION ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE S50 PLUS ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE EPOCH ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LOW PROFILE SUCTION (LPS) ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LARGE DIAMETER SUCTION (LDS) ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode without Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode with Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE SMALL DIAMETER SUCTION ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE S50 PLUS ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE EPOCH ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LOW PROFILE SUCTION (LPS) ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LARGE DIAMETER SUCTION (LDS) ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode without Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode with Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Wedge Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR VUE Wireless Footswitch2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR VUE Generator2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Side Effect Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
S90 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
P50 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Hook Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode without Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
CoolPulse 90 Electrode with Hand Controls2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Wedge Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Side Effect Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
S90 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
P50 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE VAPRFLEX SIDE EFFECT (FLEX SIDE EFFECT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE TC ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE SMALL DIAMETER SUCTION ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE SIDE EFFECT ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE S50 PLUS ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE HOOK ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE EPOCH ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE ANGLED SIDE EFFECT ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE 2.3 WEDGE ELECTRODE (STANDARD)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE 2.3 WEDGE ELECTRODE (SHORT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE 2.3 SIDE EFFECT ELECTRODE (SHORT)2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
ONE PIECE 2.3 END EFFECT ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Hook Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Wedge Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Side Effect Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
S90 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
P50 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Hook Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Wedge Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Side Effect Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
S90 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
P50 Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Hook Hand Switching2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR TC ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
VAPR TC ELECTRODE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
RD SHORT WEDGE (2.3mm WEDGE (SHORT)) RD STANDARD WEDGE 2.3mm WEDGE2017-01-09
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Morcellator2016-12-01
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Morcellator2016-12-01
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma V; Gyrus Urology Kit; Plasma Cise; Plasma Cut2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma V; Gyrus Urology Kit; Plasma Cise; Plasma Cut2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PKS BiLL2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Superpulse System Generator Model 7440002016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Superpulse System Generator Model 7440002016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Button2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PKS PlasmaSORD2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PKS PlasmaSORD2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
G400 Workstation2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
OPI; RND; SOPI2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus G3 Generator2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LPS electrode; Suction electrode2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
LPS electrode; Suction electrode2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Versapoint2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Cord; PK generator; SuperLoop; SuperPulse generator; SuperSect2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Cogent 12016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Cord; Gyrus PK Footswitch2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Generator; PlasmaKinetic System2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma Sect Urology2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma Sect Urology2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma Sect Urology2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Gyrus Plasma Sect Urology2016-11-28
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
Monopolar single-use HF cable2016-05-11
GYRUS MEDICAL LTD. [Olympus Winter & Ibe GmbH]
PK Lap Loop2014-12-12
GYRUS MEDICAL LTD.
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)2004-09-10
GYRUS MEDICAL LTD.
PLASMAKINETIC ENDOUROLOGY SYSTEM2000-12-19
GYRUS MEDICAL LTD.
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE2000-04-28
GYRUS MEDICAL LTD.
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE1999-12-27
GYRUS MEDICAL LTD.
GYRUS HYSTEROSCOPIC RESECTOSCOPE1999-12-03
GYRUS MEDICAL LTD.
GYRUS ENDOUROLOGY SYSTEM1999-06-29
GYRUS MEDICAL LTD.
GYRUS HYSTEROSCOPIC RESECTOSCOPE1999-01-21
GYRUS MEDICAL LTD.
DILECTRON URINARY CONDUCTIVITY PROBE1990-05-01

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020051426080Southhampton,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT3 CTN
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