Acme Monaco Corp

FDA Filings

This page includes the latest FDA filings for Acme Monaco Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Acme Monaco Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Acme Monaco Asia Pte. Ltd.

FDA Registration(s)

• Registration Number: 3007064586
• FEI Number: 3007064586
• Name: Acme Monaco Asia Pte. Ltd.
• Owner & Operator: ACME-MONACO CORP.
• Contact Address: 75 WINCHELL DR. --; New Britain CT 06052 US
• Official Correspondent:
  • MICHAEL - KARABIN
  • x-860-2241349-x
• US Agent:
  • MICHAEL - KARABIN
  • ACME-MONACO CORP.
  • 860 2241349
  • acmecorp@acmemonaco.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Genting Link, No. 04-05/06 Perfect One ; Singapore Not Applicable, 349518 SG
• Establishment Type: Manufacture Medical Device

• Registration Number: 1293141
• FEI Number: 1293141
• Name: ACME-MONACO CORP.
• Owner & Operator: ACME-MONACO CORP.
• Contact Address: 75 WINCHELL DR. --; New Britain CT 06052 US
• Official Correspondent:
  • MICHAEL - KARABIN
  • x-860-2241349-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 75 Winchell Rd ; NEW BRITAIN, CT 06052 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1222301
• FEI Number: 1000121071
• Name: ACME-MONACO CORP.
• Owner & Operator: ACME-MONACO CORP.
• Contact Address: 75 WINCHELL DR. --; New Britain CT 06052 US
• Official Correspondent:
  • MICHAEL - KARABIN
  • x-860-2241349-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1450 Central Drive ; PRESQUE ISLE, ME 04769 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID D972AMC1925LMRGM0 Acme Monaco Corporation	Archwire	2024-09-30
GUDID D972AMC1818UNAT0 Acme Monaco Corporation	Archwire	2024-09-30
GUDID D972AMC1616LGRST0 Acme Monaco Corporation	Archwire	2024-09-30
GUDID D972AMC1030NTI150 Acme Monaco Corporation	Spring	2024-09-30
GUDID D97277G0U219250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0U218250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0U217250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0U216220 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0U200180 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0U200160 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L219250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L218250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L217250 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L216220 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L200180 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97277G0L200160 Acme Monaco Corporation	Archwire	2024-09-25
GUDID D97267022020120 Acme Monaco Corporation	Ligature	2024-09-25
GUDID D97261014020130 Acme Monaco Corporation	Spring	2024-09-25
GUDID D972AMC215COAX300 Acme Monaco Corporation	Coil	2024-08-09
GUDID D97273L00219252 Acme Monaco Corporation	Straight Wire	2024-08-01
GUDID D97273L00217250 Acme Monaco Corporation	Straight Wire	2024-08-01
GUDID D97273L00216222 Acme Monaco Corporation	Straight Wire	2024-08-01
GUDID D97273C0U221250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0U219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0U218250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0U217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0U216220 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0L221250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0L219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0L218250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0L217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273C0L216220 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273B0U219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273B0U217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273B0L219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273B0L217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U221250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U218250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U216220 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U200180 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0U200160 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L221250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L219250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L218250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L217250 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L216220 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D97273A0L200180 Acme Monaco Corporation	Archwire	2024-08-01
GUDID D972AMC1616RCUL0 Acme Monaco Corporation	Archwire	2024-07-24
GUDID D972AMC1925RST0 Acme Monaco Corporation	Archwire	2024-06-25
GUDID D972AMC1925UNATLGNT0 Acme Monaco Corporation	Archwire	2024-06-21
GUDID D972AMC192534MMUOF1TST0 Acme Monaco Corporation	Arch Wire	2024-06-11
GUDID D972AMC10X30X36C1 Acme Monaco Corporation	Spring	2024-06-11
GUDID D972AMC195UNCOAXST0 Acme Monaco Corporation	Archwire	2024-05-28
GUDID D972AMC175UNCOAXST0 Acme Monaco Corporation	Archwire	2024-05-28
GUDID D972AMC14UGRM0 Acme Monaco Corporation	Archwire	2024-05-27
GUDID D972NFSS70 Acme Monaco Corporation	Straight Wire	2024-05-06
GUDID D972AMC123021OPN0 Acme Monaco Corporation	Coil	2024-05-03
GUDID D972AMC10X30X36C0 Acme Monaco Corporation	Coil	2024-05-02
GUDID D972AMC1725UGRM0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC172538MMS0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC172532MMS0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC172530MMS0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC172528MMS0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC1622LGRM0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC162230MMS0 Acme Monaco Corporation	Archwire	2024-04-17
GUDID D972AMC10ANGLIG500B0 Acme Monaco Corporation	Ligature	2024-04-17
GUDID D972AMC1622UMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1622UMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1622LNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1622LNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1622LMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1622LMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616UNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616UNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616UMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616UMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616LNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616LNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616LMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC1616LMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14UNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14UNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14UMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14UMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14LNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14LNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14LMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC14LMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12UNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12UNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12UMNITI0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12UMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12LNATLGST0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12LNATLGNT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12LMNITI2 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC12LMNAT0 Acme Monaco Corporation	Archwire	2024-04-16
GUDID D972AMC11LIG0 Acme Monaco Corporation	Ligature	2024-04-16
GUDID D972AIR12LIG0 Acme Monaco Corporation	Ligature	2024-04-16
PMN K101199 | KNT ACME-MONACO CORP.	Guidewire	2013-06-06
PMN K113162 | DQX ACME-MONACO CORP.	Acme Monaco Slidewire	2012-10-26
PMN K113162 ACME-MONACO CORP.	SLIDEWIRETM(TRADEMARK PENDING)	2012-07-20
PMN K992664 | DRB ACME-MONACO CORP.	Multiple	2007-11-27
PMN K992664 | DRB ACME-MONACO CORP.	Multiple	2007-11-27
PMN K920884 | DQX Acme Monaco Asia Pte. Ltd. [ACME-MONACO CORP.]	Multiple	2007-11-27
PMN K920884 | DQX ACME-MONACO CORP.	Multiple	2007-11-27
PMN K920884 | DQX ACME-MONACO CORP.	Multiple	2007-11-27
PMN K920884 ACME-MONACO CORP.	GUIDEWIRES, VARIOUS TYPES	1992-08-19
FZX ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
EJF ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
EJF ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
ECO ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
ECO ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
ECN ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
ECN ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
DZC ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
DZC ACME-MONACO CORP.	MULTIPLE PRODUCTS	1992-08-06
PMN K895854 ACME-MONACO CORP.	ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)	1990-04-09
PMN K895483 ACME-MONACO CORP.	ACME COATED ORTHODONTIC ARCHWIRE	1990-01-29
PMN K883763 ACME-MONACO CORP.	ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH	1988-11-18