Data / Medical devices / Switzerland / Keri Medical

Keri Medical: FDA-registered device maker in Plan-les-Ouates Geneve, Switzerland, 1 510(k) clearance and 1 PMA approval

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

Keri Medical is registered with the FDA (registration 3024706750) in Plan-les-Ouates Geneve, Switzerland. It lists 9 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Keri Medical

FDA registration number: 3024706750
Address: Chemin du Pre-Fleuri 5, Plan-les-Ouates Geneve, Switzerland, 1228
Owner or operator: Keri Medical (10085771)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: September 26, 2022
Registered through: 2026
Brand names listed: BONE AWL, Conical Cup Pattern 10, Conical Cup Pattern 9, K-Wire Centering Guide, KERIFLEX LID, KERIFLEX TRAY, KeriFlex, Kirschner wire and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Finger, Constrained, Polymer	KYJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Finger, Semi-Constrained, Metal/Polymer	SFA	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Starter, Bone Screw	HWD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, 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
July 27, 2022	K211385	KeriFlex® MCP and PIP Finger Joint Prostheses	KYJ	Substantially Equivalent	Keri Medical SA	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
July 10, 2025	P240020	TOUCH® CMC 1 Prosthesis	SFA	6	June 24, 2026	accessdata.fda.gov

Compare with other makers

Updated June 24, 2026. 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.