Hologic Surgical Products Costa Rica S R L

FDA Filings

This page includes the latest FDA filings for Hologic Surgical Products Costa Rica S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007200016
• FEI Number: 3007200016
• Name: Hologic Surgical Products Costa Rica, S.R.L.
• Owner & Operator: HOLOGIC, INC.
• Contact Address: 250 Campus Drive --; Marlborough MA 01752 US
• US Agent:
  • Neil Kelly
  • Hologic, Inc
  • 508 2638634
  • neil.kelly@hologic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 562 Parkway Ave 0 Coyol Free Zone; El Coyol Alajuela, 00000 CR
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
IZD Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TruNode Gamma Probe System	2020-01-23
PMN K132665 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	PELLEVE GLIDESAFE	2019-12-16
PMN K190813 | PON Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Definity	2019-10-08
PMN K191281 | QHZ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Omni Lok	2019-08-30
PMN K191281 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Omni Lok	2019-08-30
PMN K190678 | PBX Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TempSure System	2019-08-06
PMN K190678 | PBX Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TempSure Firm	2019-08-06
PMN K190678 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TempSure System	2019-08-06
PMN K190678 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TempSure Firm	2019-08-06
PMN K172566 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure	2019-05-29
ODR Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Neutral Plate	2019-02-12
PMN K182365 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	TempSure System	2019-01-09
PMN K171262 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Tempsure	2018-11-05
ELR Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Glass Fibre Post	2018-11-05
EJL Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Roto-Pro Rotosonic Scalers	2018-11-05
PMN K132949 | PBX Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Pellefirm HPs	2018-09-17
HNI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Chedley Eyelid Retractor	2018-09-17
HDL Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Vaginal Retractor	2018-09-17
HDF Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Speculum	2018-09-17
GAX Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	ELLMAN DIGIT TOURNIQUETS	2018-09-17
EKG Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Silva-Packer	2018-09-17
EIG Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Self Span Cheek and Lip Retractors	2018-09-17
EBL Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Nubond Post, Screw	2018-09-17
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Tongue Base Reduction Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Sub-Mucosal VTR (UPP) Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile RF Suction Coagulator	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile RF Angled Suction Coagulator	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile RAUP Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile MicroInsulated Needles	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Micro Fibre? Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile LLETZ Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile LLETZ Bayonet Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile IEC-XBHP3	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile IEC-3FHPB/D	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Empire Microlncision	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Dermatology Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Clear-Vu? Bayonet Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sterile Beigi Minimally Invasive Entropion Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Suction Coagulator Kit (H40)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Standard Podiatry Electrodes (S11B)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Round Loop Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Rodin? Microsurgery Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Rhinophyma Electrode Set	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable RF Wedge Resection Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable RF Myringotomy Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable RF Laparoscopic Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable RF Laparoscopic Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable RF Assisted Tonsillotomy (RAT) Ball Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Patented 1 Button Fingerswitch Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Oval Loop Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Ophthalmic Micro-Dissection Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable OTO-RAM Radiofrequency Assisted Myringotomy Handpieces (IEC-EE600/IEC-H604)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable OTO-RAM Probe (1.5mm/2.0mm)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Needle Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable MicroInsulated Needle Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable MicroInsulated Needle Handpiece with Locking Chuck	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Micro-Larynx RF Probes (Loop/Needle/Ball)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable LLETZ Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable LLETZ Bayonet Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Javate/Khan RF Endoscopic Forehead Suction Probe	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Javate/Khan Endo Forehead Suction Kit	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Javate/Khan Coated Spade Suction Probe	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Javate/Khan Coated Flate Scalpel Suction Probe	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Javate Endoscopic DCR Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Insulated Sclerotherapy Needles	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Insulated Needle Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Insulated Matrixectomy Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Giosis RF Elevator	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Foot-Controlled Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable External Genital Lesion RF Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Empire MicroTip Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Cryptolysis Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Conization Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Chedly Pucntal Occlusion (CPO) Electrodes	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Blade Handpiece	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Baker Brow Probe	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Adenoid RF Electrode	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable 3" Length Handpiece with Patented Locking Chuck (XLP1)	2018-09-07
JOS Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable 3" Length Handpiece with Patented Locking Chuck (IEC-XLP1)	2018-09-07
PMN K964176 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Reusable Bipolar Electrosurgical Forceps	2018-08-29
PMN K102698 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Pelleve Glidesafe Handpiece	2018-08-29
PMN K071343 | GEI Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Ace-Tip Elecctrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe, RF Suction Adenoid Probes, Noble Alloy Electrodes	2018-08-29
PMN K181974 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure XL TRD for Fluent	2018-08-23
PMN K180825 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Fluent	2018-08-03
PMN K180825 | HIG Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Fluent	2018-08-03
PMN K173901 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Tissue Removal Device	2018-05-14
PMN K180233 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Eviva Stereotactic Breast Biopsy Device	2018-04-16
PMN K163052 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Brevera Breast Biopsy System with Corlumina Imaging Technology	2017-04-06
GDF Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sertera Introducer Set	2016-06-03
PMN K152723 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Reach	2015-11-16
PMN K150169 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Sertera Biopsy Device	2015-08-14
PMN K142029 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Tissue Morcellation System	2015-05-04
PMN K131736 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure Next Generation XL Tissue Removal Device	2013-08-27
PMN K131581 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure NG Classic Tissue Removal Device	2013-08-27
PMN K120593 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure Control Unit	2013-05-01
PMN K122498 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure XL TRD	2012-09-12
PMN K121868 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure Lite	2012-07-26
PMN K102768 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	SecurMark	2011-03-03
PMN K102608 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	SecurMark	2011-03-03
PMN K072913 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	SecurMark	2011-03-03
PMN K102686 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Single Use Seals	2011-02-17
PMN K100559 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Hysteroscopic Tissue Removal System	2011-02-17
PMN K091100 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Hysteroscopic Tissue Removal System	2011-02-17
PMN K081070 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure Operative Hysteroscope	2011-02-17
PMN K073690 | HIH Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Myosure Tissue Morcellation Device	2011-02-17
NWW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MyoSure Manual Tissue Removal Device	2010-06-17
PMN K092405 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite ML	2009-09-02
PMN K030558 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite RTS system 5-6 balloon	2009-04-13
PMN K081179 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite Cavity Evaluation Device	2008-07-30
PMN P010013 | MNB Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	NovaSure RF Controller	2008-04-09
PMN P010013 | MNB Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	NovaSure EndometrialAblation System	2008-04-09
PMN P010013 | MNB Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	NovaSure Device (Handpiece)	2008-04-09
PMN K032067 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite Radiation Therapy System	2008-01-21
PMN K032067 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite 4-6 balloon	2008-01-21
PMN K011690 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite Radiation Therapy System	2008-01-21
PMN K011690 | JAQ Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	MammoSite 4-5 balloon & Afterloader	2008-01-21
PMN K062528 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Trimark	2008-01-03
PMN K062528 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	CeleroMark	2008-01-03
PMN K034021 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Celero	2007-11-05
PMN K023450 | NEU Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Trimark	2007-11-05
PMN K010400 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Instrument, Biopsy	2007-11-05
PMN K010400 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	ATEC	2007-11-05
PMN K042290 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Tissue Filter	2003-01-16
PMN K042290 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Needle Guides	2003-01-16
PMN K042290 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Introducer Localization Set (ILS)	2003-01-16
PMN K042290 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Eviva	2003-01-16
PMN K042290 | KNW Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	ATEC	2003-01-16
JAC Hologic Surgical Products Costa Rica, S.R.L. [HOLOGIC, INC.]	Marker Wire Kit	1992-07-14