HomeUSASPAN-AMERICA MEDICAL SYSTEMS, INC.

SPAN-AMERICA MEDICAL SYSTEMS, INC.

USA · Greenville
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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
14listed device types
Class I 13Class II 1Class III 0
plus 14 registration records and 19 510(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
3active device licences
Class II 3
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 8
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 States14 registration records, 19 510(k), 0 PMA, 3 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: SPAN-AMERICA MEDICAL SYSTEMS, INC. · SPAN-AMERICA MEDICAL SYSTEMS INC.

Company information

Country
USA
City
Greenville

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11980
11985
21987
11988
21989
11993
31995
61996
21998

FDA listed device types

showing 8 of 14
Protector, Skin Pressure 1Sling, Overhead Suspension, Wheelchair 1Support, Patient Position 1Splint, Abduction, Congenital Hip Dislocation 1Surgical Table Cushion 1Cover, Mattress (Medical Purposes) 1Mattress, Flotation Therapy, Non-Powered 1Aid, Transfer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK973169PRESSURE GUARD SITE SELECT (A)1998-02-20
USK972486PRESSUREGUARD IV1998-02-20
USK960188PRESSUREGUARD: SELECTCARE1996-10-02
CA2061PRESSUREGUARD SITE SELECTClass II
CA2062PRESSUREGUARD TURN SELECTClass II
CA70594AIRLIFT ALTERNATING PRESSURE MATTRESS WITH TRADITIONAL LOW AIR LOSSClass II

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