FIVE STAR MANUFACTURING, INC.

Contract manufacturer · New Bedford, MA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2007Product codes first listed, by year (tallest: 12)2026

FDA registration: 3004513872 (openFDA record; or search FDA's registration database)
FEI number: 3004513872
Registered for: FDA registration year 2026
Establishment types: Specification developer; Manufacturer; Contract manufacturer
Owner or operator: FIVE STAR MANUFACTURING, INC. (FDA owner/operator no. 9061981)
Registered address: 163 SAMUEL BARNET BLVD., New Bedford, MA 02745
Contract listings: 32 device listings, 39 product codes, first listed Apr 18, 2007
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
FSP	Loupe, Diagnostic/Surgical	Class I	General and plastic surgery	Contract manufacturing	Apr 18, 2007
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2018
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jun 28, 2022
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Aug 27, 2021
GFC	Driver, Surgical, Pin	Class I	General and plastic surgery	Contract manufacturing	Jan 29, 2019
GZT	Retractor, Self-Retaining, For Neurosurgery	Class II	Neurology	Contract manufacturing	Aug 30, 2016
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Mar 8, 2019
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Sep 22, 2020
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Aug 23, 2018
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 29, 2019
HSO	Saw	Class I	General and plastic surgery	Contract manufacturing	Jan 7, 2022
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Aug 23, 2018
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2018
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Aug 27, 2021
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Sep 22, 2020
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2018
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Aug 23, 2018
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 7, 2022
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 29, 2019
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Aug 27, 2021
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Jul 8, 2019
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Sep 22, 2020
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract manufacturing	Sep 25, 2020
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 8, 2019
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Sep 25, 2020
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 9, 2024
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 14, 2013
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Mar 8, 2019