Data / Medical devices / Sweden / Perimed AB

Perimed AB: FDA-registered device maker in JARFALLA Stockholm, Sweden, 7 510(k) clearances

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

Perimed AB is registered with the FDA (registration 8030885) in JARFALLA Stockholm, Sweden. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 5, 2016. 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 Perimed AB

FDA registration number: 8030885
FEI number: 3003244961
Address: Datavagen 9 A, JARFALLA Stockholm, Sweden, 17543
Owner or operator: PERIMED AB (8030885)
Roles: Complaint file establishment, Manufacturer
First device listed: December 26, 2007
Registered through: 2026
Brand names listed: PF 105-3 Double-Sided Tape Strips, PF 6001 Main Unit, PF 6001 Main Unit Complete, PF 6010 LDPM/Temp Unit, PF 6040 tcpO2/pCO2 Unit, PF 6050 Pressure Unit, PF 6051 Pressure Accessory Kit, PF 6051-M Pressure Accessory Kit Metal Bayonet and more

Devices it lists

Device	Product code	Class	Role	Source
Flowmeter, Blood, Cardiovascular	DPW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Probe, Blood-Flow, Extravascular	DPT	2	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
May 5, 2016	K152930	PeriFlux6000	DPW	Substantially Equivalent	Perimed AB	accessdata.fda.gov
October 22, 2013	K131253	PERIFLUX 6000	LKD	Substantially Equivalent	Perimed AB	accessdata.fda.gov
July 3, 2012	K120884	PERICAM PSI	DPT	Substantially Equivalent	Perimed AB	accessdata.fda.gov
September 23, 1999	K990960	PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)	LKD	Substantially Equivalent	Perimed, Inc.	accessdata.fda.gov
May 28, 1998	K974285	PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT	DPW	Substantially Equivalent	Perimed, Inc.	accessdata.fda.gov
April 18, 1994	K935495	PF404/409/410/411/416/418 W/PF319:0/319:1/319:2	GEX	Substantially Equivalent	Perimed, Inc.	accessdata.fda.gov
December 7, 1993	K932068	PERITEMP PF 4005 HEATER	DPW	Substantially Equivalent	Perimed, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 5, 2016. 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.