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GRACE MEDICAL, INC.

USA · Memphis

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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

23listed device types

Class I 14Class II 9Class III 0

plus 33 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 6Class II 2

16 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 1Class III 1

17 including historic records

TWTaiwanTFDA

6valid device licences

Class I 2Class II 4

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

19active ARTG entries

Class I 8IIa 8IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 States33 registration records, 14 510(k), 0 PMA, 8 excluded

Brazil8 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: GRACE MEDICAL, INC. · GRACE MEDICAL, INC

FDA 510(k) clearances by year

11994

11996

11997

11998

11999

52006

12008

12009

12016

12023

FDA listed device types

showing 8 of 23

Tube, Ear Suction 1Instrument, Ent Manual Surgical 1Gauge, Measuring 1Blower, Powder, Ent 1Retractor, Ent 1Bur, Ear, Nose And Throat 1Dressing, Compression 1Forceps, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232059	Tympanostomy Tubes	2023-11-24
US	K161376	DragonFly Surgical Drill System	2016-08-25
US	K091187	GRACE DYNAMIC TORP	2009-09-14
BR	81363880016	INSTRUMENTOS DIAMANTADOS OLSON PARA COLESTEATOMA	Class I
BR	81363889001	Sistema de Perfuração Cirúrgica DragonFly	Class II
BR	81363880017	PINÇA DE CORTE PARA SISTEMA AJUSTÁVEL ALTO	Class I
CA	97965	ACCUTIP AND DRAPE	Class II
CA	112299	TYMPANOSEAL W/INSTRUMENT	Class III

GRACE MEDICAL, 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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