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Medical Specialties Intl., Inc.

USA · South Plainfield

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

12listed device types

Class I 12Class II 0Class III 0

plus 12 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 6Class III 2

36 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 States12 registration records, 45 510(k), 0 PMA, 70 excluded

Brazil0 confirmed, 9 excluded

Canada8 confirmed, 12 excluded

Manufacturer names merged into this page: MEDICAL SPECIALTIES, INC. · MEDICAL SPECIALTIES INC. · DENTSPLY TULSA DENTAL SPECIALTIES A DIV OF DENTSPLY INTL INC TRADING AS UNITED DENTAL MFRS · DENTSPLY TULSA DENTAL SPECIALTIES A DIV OF DENTSPLY INTL INC TRADING AS DENTSPLY MAILLEFER

FDA 510(k) clearances by year

21979

11983

231984

11985

11986

21987

51988

11989

11990

31993

31995

21997

FDA listed device types

showing 8 of 12

Orthosis, Limb Brace 1Joint, Knee, External Brace 1Binder, Abdominal 1Knife, Surgical 1Sling, Arm 1Applier, Surgical, Clip 1Splint, Hand, And Components 1Orthosis, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K972655	CONTROL SYRINGE	1997-11-04
US	K972654	MANIFOLD	1997-10-08
US	K952385	HEMA-TROL Q-CHECK	1995-09-25
CA	76656	K-REAMER	Class II
CA	76657	C-FILES	Class II
CA	76658	HEDSTROM FILES	Class II

Medical Specialties Intl., 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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