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Summit Medical Products, Inc.

USA · Sandy

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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

49listed device types

Class I 33Class II 13Class III 0unclassified 3

plus 62 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 7Class II 10

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

15active device licences

Class II 13Class III 2

44 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 States62 registration records, 18 510(k), 0 PMA, 31 excluded

Brazil17 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada15 confirmed, 2 excluded

Manufacturer names merged into this page: SUMMIT MEDICAL LLC · SUMMIT MEDICAL LTD. · SUMMIT MEDICAL, INC. · SUMMIT MEDICAL PRODUCTS, INC. · SUMMIT MEDICAL, LLC · SUMMIT MEDICAL LIMITED

FDA 510(k) clearances by year

22002

12003

32011

42014

32015

32017

22018

FDA listed device types

showing 8 of 49

Dispenser, Cement 1Clamp, Surgical, General & Plastic Surgery 1Speculum, Vaginal, Metal 1Tube, Ear Suction 1Stand, Infusion 1Cannula, Surgical, General & Plastic Surgery 1Splint, Intranasal Septal 1Punch, Biopsy, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180528	InstruSafe(R) Sterilization Container	2018-11-16
US	K173110	GRAFTSITE	2018-05-18
US	K162165	ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump	2017-08-29
BR	80537069002	Misturador de Cimento Ósseo - HiVac Bowl	Class II
BR	80537069003	Sistema de Mistura e Aplicação de cimento Ósseo - HiVac 7 & HiVac Syr	Class II
BR	80537069004	HiVac 7 com Pressurizador Femoral (Sistema de Mistura e distribuição d	Class II
SA	ME0000011525SFDAA00002	INSTRUSAFE	—
SA	ME0000011525SFDAA00003	TipVision	—
CA	86478	AMBIT PEELABLE SHEATH INTRODUCER	Class II
CA	86479	AMBIT TUNNELER	Class II
CA	101796	MICROI BLADE	Class II

Summit Medical Products, 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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