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Zap Surgical Systems, Inc.

USA · San Carlos

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States2 registration records, 4 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: ZAP SURGICAL SYSTEMS INC. · ZAP SURGICAL SYSTEMS, INC.

Market	Identifier	Name	Class / date
US	K250392	ZAP-X Radiosurgery System (ZAP-X)	2025-11-03
US	K211663	Zap-X Radiosurgical System	2021-07-29
US	K183698	Zap-X Radiosurgery System	2019-02-25

Zap Surgical Systems, 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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