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OSTEOGENICS BIOMEDICAL, INC.

USA · Lubbock

✓ 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

11listed device types

Class I 3Class II 7Class III 0unclassified 1

plus 17 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class IV 1

7 including historic records

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 States17 registration records, 9 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: OSTEOGENICS BIOMEDICAL, INC. · osteogenics biomedical, inc

FDA 510(k) clearances by year

11999

22000

12002

12007

12010

12015

12017

12021

FDA listed device types

showing 8 of 11

Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Plate, Bone 1Barrier, Synthetic, Intraoral 1Screw, Fixation, Intraosseous 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Bone Grafting Material, Synthetic 1Tray, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201187	Cytoplast Titanium-Reinforced PTFE Membranes	2021-01-23
US	K171774	RPM Reinforced PTFE Mesh	2017-10-19
US	K141177	VITALA PORCINE DERIVED COLLAGEN MEMBRANE	2015-09-15
BR	80117580486	Cytoplast PTFE Suture	Class II
BR	80117580158	Cytoplast Regentex Non-Resorbable Barrier Membranes, Titanium-Reinforc	Class II
BR	80117580161	Cytoplast Regentex Non-Resorbable Barrier Membranes	Class II
CA	97665	VITALA PORCINE DERIVED COLLAGEN MEMBRANE	Class IV

OSTEOGENICS BIOMEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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