Data / Medical devices / United Kingdom / Altomed Ltd.

Altomed Ltd.: FDA-registered device maker in Boldon Colliery South Tyneside, United Kingdom, 1 510(k) clearance

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

Altomed Ltd. is registered with the FDA (registration 9614107) in Boldon Colliery South Tyneside, United Kingdom. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614107
FEI number: 3002867000
Address: 14 Burford Way, Boldon Colliery South Tyneside, United Kingdom, NE35 9PZ
Owner or operator: ALTOMED LTD. (9043181)
Roles: Manufacturer, Specification developer
First device listed: October 3, 2000
Registered through: 2026
Brand names listed: Altomed, Altomed Malhotra Platinum Segments, Malhotra Endonasal DCR Nibbler Delicate, Traquair Periosteal Elevator

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Ophthalmic	HMX	1	Manufacturer	accessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	MXY	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Clip, Lens, Trial, Ophthalmic	HPB	1	Manufacturer, Specification developer	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer	accessdata.fda.gov
Marker, Sclera	HMQ	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Punch, Nasal	KAY	1	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Manufacturer	accessdata.fda.gov
Ring, Ophthalmic (Flieringa)	HNH	1	Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Manufacturer	accessdata.fda.gov
Spoon, Ophthalmic	HNB	1	Manufacturer	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	1	Manufacturer	accessdata.fda.gov
Weights, Eyelid, External	MML	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2017	K170591	Altomed Malhotra Platinum Segments	MML	Substantially Equivalent	Altomed Limited	accessdata.fda.gov

Compare with other makers

Updated June 6, 2017. 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.