Lexington Medical Inc

FDA Filings

This page includes the latest FDA filings for Lexington Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012998149
• FEI Number: 3012998149
• Name: LEXINGTON MEDICAL, INC.
• Owner & Operator: Lexington Medical, Inc.
• Contact Address: 11 Executive Park Drive ; North Billerica MA 01862 US
• Official Correspondent:
  • Marc Jin
  • 1-617-2099817-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 11 EXECUTIVE PARK DR ; North Billerica, MA 01862 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850060791154 LEXINGTON MEDICAL, INC.	AEON	2025-05-09
GUDID 00850060791130 LEXINGTON MEDICAL, INC.	AEON	2025-02-26
GUDID 00850060791109 LEXINGTON MEDICAL, INC.	AEON	2025-01-17
GUDID 00851574008639 LEXINGTON MEDICAL, INC.	AEON	2024-06-03
GUDID 00851574008479 LEXINGTON MEDICAL, INC.	AEON	2024-06-03
GUDID 00851574008356 LEXINGTON MEDICAL, INC.	AEON	2024-06-03
GUDID 00851574008790 LEXINGTON MEDICAL, INC.	AEON	2024-01-09
GUDID 00851574008059 LEXINGTON MEDICAL, INC.	AEON	2024-01-09
GUDID 00851574008653 LEXINGTON MEDICAL, INC.	AEON	2023-08-28
GUDID 00851574008486 LEXINGTON MEDICAL, INC.	AEON	2023-08-28
GUDID 00851574008370 LEXINGTON MEDICAL, INC.	AEON	2023-08-28
GUDID 00851574008752 LEXINGTON MEDICAL, INC.	AEON	2023-06-22
GUDID 00851574008646 LEXINGTON MEDICAL, INC.	AEON	2023-06-22
GUDID 00851574008592 LEXINGTON MEDICAL, INC.	AEON ASR30RC	2022-01-03
GUDID 00851574008578 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008554 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008530 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008516 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008455 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008431 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008417 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008394 LEXINGTON MEDICAL, INC.	AEON	2022-01-03
GUDID 00851574008332 LEXINGTON MEDICAL, INC.	AEON	2021-10-04
GUDID 00851574008318 LEXINGTON MEDICAL, INC.	AEON	2021-07-13
GUDID 00851574008141 LEXINGTON MEDICAL, INC.	AEON	2021-07-13
GUDID 00851574008233 LEXINGTON MEDICAL, INC.	AEON	2021-05-04
GUDID 00851574008219 LEXINGTON MEDICAL, INC.	AEON	2021-05-04
GUDID 00851574008196 LEXINGTON MEDICAL, INC.	AEON	2021-05-04
GUDID 00851574008271 LEXINGTON MEDICAL, INC.	AEON	2021-03-29
GUDID 00851574008257 LEXINGTON MEDICAL, INC.	AEON	2021-03-29
GUDID 00851574008172 LEXINGTON MEDICAL, INC.	AEON	2021-03-29
GUDID 00851574008134 LEXINGTON MEDICAL, INC.	AEON	2021-02-09
PMN K201882 Lexington Medical Inc.	AEON Endoscopic Stapler	2020-10-09
PMN K192235 Lexington Medical, Inc.	AEON Laparoscopic Instruments	2019-10-11
GUDID 00851574008981 LEXINGTON MEDICAL, INC.	AEON	2019-09-06
GUDID 00851574008967 LEXINGTON MEDICAL, INC.	AEON	2019-09-06
GUDID 00851574008905 LEXINGTON MEDICAL, INC.	AEON	2019-09-06
GUDID 00851574008882 LEXINGTON MEDICAL, INC.	AEON	2019-09-06
GUDID 00851574008110 LEXINGTON MEDICAL, INC.	AEON	2019-09-06
GUDID 00851574008943 LEXINGTON MEDICAL, INC.	AEON	2019-06-27
GUDID 00851574008929 LEXINGTON MEDICAL, INC.	AEON	2019-06-27
GUDID 00851574008844 LEXINGTON MEDICAL, INC.	AEON	2019-06-27
GUDID 00851574008684 LEXINGTON MEDICAL, INC.	AEON	2018-12-18
PMN K182380 Lexington Medical, Inc.	AEON Endoscopic Stapler	2018-11-28
GUDID 00851574008868 LEXINGTON MEDICAL, INC.	AEON	2018-09-24
GUDID 00851574008820 LEXINGTON MEDICAL, INC.	AEON	2018-08-15
GUDID 00851574008806 LEXINGTON MEDICAL, INC.	AEON	2018-08-15
GUDID 00851574008783 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008745 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008721 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008660 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008080 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008066 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008028 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
GUDID 00851574008004 LEXINGTON MEDICAL, INC.	AEON	2018-07-06
PMN K180114 | GCJ LEXINGTON MEDICAL, INC.	AEON Retrieval Bag	2018-05-16
GUDID 00851574008707 LEXINGTON MEDICAL, INC.	AEON	2018-04-19
PMN K180114 Lexington Medical Inc.	AEON Retrieval Bag	2018-03-27
PMN K173443 Lexington Medical Inc.	AEON Endoscopic Stapler	2018-02-01
PMN K171589 | GDW LEXINGTON MEDICAL, INC.	AEON Endoscopic Stapler	2017-11-20
PMN K171589 Lexington Medical Inc.	AEON Endoscopic Stapler	2017-11-17

Related Finance Registrations

NCAGE Code	825B8	LEXINGTON MEDICAL, INC.
CAGE Code	825B8	LEXINGTON MEDICAL, INC.
S.A.M. Registration	825B8 [79881514]	LEXINGTON MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090414705	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL DEVICE	26 CTN
2020082027392	Shanghai ,China (Mainland) -> Boston, Massachusetts	SHIPPING COVER 50CTNS=1PALLET AMSKYSI BO	50 CTN
202004159675	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL DEVICE	16 CTN
2020040612298	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PLASTIC PART PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL DEVICE	152 CTN
2020032033572	Yantian,China (Mainland) -> New York, New York	PLASTIC PART PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL DEVICE	152 CTN
201810045909	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SHIPPING COVER 4 0 REV A SHIPPING COVER 5 0	67 CTN
201809138282	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PLASTIC PART PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL	75 CTN
2018090819370	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PLASTIC PART PART ASSEMBLED INTO SINGLE USE ENDOMECHANICAL SURGICAL	75 CTN