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Oscor, Inc.

USA · Palm Harbor

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 1Class II 8Class III 5

plus 41 registration records and 49 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 3Class IV 6

37 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

4device registrations

CLASS C 2CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 3Class III 8IIa 1IIb 3Class Is (sterile) 1

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 1Class 3 4

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 States41 registration records, 49 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: OSCOR INC. · OSCOR INC · OSCOR INC,

FDA 510(k) clearances by year

21979

21982

151983

11984

32001

12002

32003

22004

22007

32008

12009

22010

42012

12013

42014

22015

12021

FDA listed device types

showing 8 of 14

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea 1Acute Coronary Syndrome Event Detector 1Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 1Permanent Pacemaker Electrode 1Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief 1Stimulator, Spinal-Cord, Implanted (Pain Relief) 1Cable, Electrode 1Catheter, Flow Directed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210627	Breezeway II	2021-06-03
US	K151951	Destino Reach	2015-09-22
US	K143463	IS4/DF4 Port Plug	2015-03-19
BR	80065320173	INTRODUTOR SAFESHEATH CSG	Class II
BR	10256400076	Adelante® Sigma TKit	Class II
BR	10256400077	ADELANTE® SIGMA WTKIT	Class II
CA	6959	SUBCLAVIAN PEEL-AWAY INTRODUCER SET	Class II
CA	8802	NON-IMPLANTABLE LEAD ACCESSORIES AND STYLETS	Class II
CA	10170	RT AND RU SERIES IMPLANTABLE ENDOCARDIAL PACING LEADS	Class IV

Oscor, 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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