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TYBER MEDICAL, LLC.

USA · Bethlehem

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

26listed device types

Class I 16Class II 10Class III 0

plus 78 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 7IIa 5IIb 9

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

4registrations

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 States78 registration records, 31 510(k), 0 PMA

Saudi Arabia5 confirmed, 0 excluded

Manufacturer names merged into this page: Tyber Medical · TYBER MEDICAL, LLC. · TYBER MEDICAL LLC · Tyber Medical, LLC

FDA 510(k) clearances by year

12013

12014

22015

22016

32017

12018

12019

32020

12021

12022

62023

12024

42025

42026

FDA listed device types

showing 8 of 26

Instrument, Cutting, Orthopedic 1Rongeur 1Rasp 1Curette, Surgical, General Use 1Template 1Reamer 1Gauge, Depth 1Screwdriver, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261207	Exalta Proximal Tibia Plating System	2026-06-12
US	K260810	Anteralign LS coverplate	2026-06-10
US	K261060	Navigated LLIF Impactable Tracker	2026-05-29
SA	ME0000003187SFDAA00009	INSTRUMENT TRAY FOR CANN SCREWS	—
SA	ME0000003187SFDAA00007	1/3 MODULAR TRAY LID	—

TYBER 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)

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