Data / Medical devices / United States / Mack Molding Company

Mack Molding Company: FDA-registered device maker in Arlington, VT, United States, 1 PMA approval

Name: Mack Molding Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mack Molding Company is registered with the FDA (registration 3000236920) in Arlington, VT, United States. It lists 21 device types. The FDA files 1 PMA approval under its listings, the newest dated April 8, 1987. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3000236920
FEI number: 1000086912
Address: 608 Warm Brook RD., Arlington, VT, United States, 05250
Owner or operator: MACK MOLDING COMPANY (9040779)
Roles: Contract manufacturer, Remanufacturer
First device listed: December 30, 2005
Registered through: 2027
Brand names listed: Attune, Depth Gauge, Elevator, Screwdriver, Therakos CellEx Photopheresis System, UVAR XTS PHOTOPHERESIS SYSTEM

Devices it lists

Device	Product code	Class	Role	Source
Centrifuge, Cell-Washing, Automated For Immuno-Hematology	KSN	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Elevator	HTE	1	Contract manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	NJL	3	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Contract manufacturer	accessdata.fda.gov
System, Photopheresis, Extracorporeal	LNR	3	Contract manufacturer, Remanufacturer	accessdata.fda.gov
System, Test, Automated Blood Grouping And Antibody	KSZ	2	Contract manufacturer	accessdata.fda.gov
Template	HWT	1	Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 8, 1987	P860003	UVAR PHOTOPHERESIS SYSTEM	LNR	107	November 21, 2025	accessdata.fda.gov

Compare with other makers

Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.