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Maxxim Medical, Inc.

USA · Athens

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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

28510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 28 510(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

6active device licences

Class II 6

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States0 registration records, 28 510(k), 0 PMA

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: MAXXIM MEDICAL, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K023236	SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2002-11-12
US	K021452	STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE	2002-08-01
US	K011905	SNIPER ELITE MODEL-OR-E3872XX SERIES	2001-08-28
CA	6103	SHAMROCK SAF-T TUBE HOLDER WITH NEEDLE	Class II
CA	6105	SAF-T CLIK TUBE HOLDER (SHIELDED BLOOD NEEDLE ADAPTER)	Class II
CA	6109	SAF-T-FLO IV LINE CONNECTION SYSTEM	Class II

Maxxim Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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