Home›USA›Parcus Medical, LLC

Parcus Medical, LLC

USA · Sarasota

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

19listed device types

Class I 14Class II 5Class III 0

plus 45 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class III 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States45 registration records, 31 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: PARCUS MEDICAL , L.L.C. · PARCUS MEDICAL, LLC · Parcus Medical L.L.C

FDA 510(k) clearances by year

52009

22010

12011

22012

12013

12014

12015

12016

22017

62019

42020

22021

22022

12023

FDA listed device types

showing 8 of 19

Passer 1Screwdriver 1Elevator 1Starter, Bone Screw 1Bit, Drill 1Extractor 1Accessories, Arthroscopic 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232513	X-Twist Biocomposite Suture Anchor	2023-09-18
US	K221502	Parcus Synd-EZ SS	2022-07-26
US	K221135	X-Twist PEEK Suture Anchor	2022-05-19
BR	80120790065	Kit Instrumental para ombro Parcus	Class I
BR	80120790066	Kit Instrumental Parcus	Class I
BR	80120790078	Sistema de Tração Parcus (PTU)	Class I
CA	82959	V-LOX PEEK CF SUTURE ANCHOR	Class III
CA	83195	GRAFT FIXATION SYSTEM (GFS)	Class III
CA	84196	PEEK CF INTERFERENCE SCREW	Class III

Parcus Medical, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies