Data / Medical devices / Czechia / Resorba, s.r.o

Resorba, s.r.o: FDA-registered device maker in Domazlice, Czechia, 4 510(k) clearances

Name: Resorba, s.r.o FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Resorba, s.r.o is registered with the FDA (registration 3014592276) in Domazlice, Czechia. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 18, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014592276
Address: Haltravska 578, Domazlice, Czechia, 34401
Owner or operator: ADVANCED MEDICAL SOLUTIONS GROUP PLC (9031453)
Roles: Manufacturer
First device listed: December 5, 2014
Registered through: 2026
Brand names listed: CAPROLON, MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL, PGA RESORBA, PGA RESOQUICK, GLYCOLON, Polyethylene terephthalate polyester non-absorbable suture (SUPOLENE)

Devices it lists

Device	Product code	Class	Role	Source
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)	MXW	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
September 18, 2018	K181320	Caprolon	GAM	Substantially Equivalent	Resorba Medical GmbH	accessdata.fda.gov
November 2, 2015	K143584	PGA RESORBA, PGA RESOQUICK, GLYCOLON	GAM	Substantially Equivalent	Resorba Medical GmbH	accessdata.fda.gov
October 29, 2015	K143582	MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL	GAW	Substantially Equivalent	Resorba Medical GmbH	accessdata.fda.gov
June 23, 2014	K141072	SUPOLENE	GAT	Substantially Equivalent	Resorba Medical GmbH	accessdata.fda.gov

Compare with other makers

Updated September 18, 2018. 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.