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American Medical Endoscopy, Inc.

USA · Miami

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, 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

34listed device types

Class I 15Class II 19Class III 0

plus 39 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 4Class II 3

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

2active device licences

Class II 2

15 including historic records

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 States39 registration records, 22 510(k), 0 PMA, 62 excluded

Brazil7 confirmed, 32 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada2 confirmed, 7 excluded

Manufacturer names merged into this page: AMERICAN MEDICAL ENDOSCOPY · AMERICAN MEDICAL ENDOSCOPY, INC.

FDA 510(k) clearances by year

121982

21983

41984 · K841384

11985 · K853274

12025 · K251652

22026 · K253020

FDA listed device types

showing 8 of 34

Forceps, Biopsy, Non-Electric 1Syringe, Irrigating (Non Dental) 1Holder, Needle, Gastroenterologic 1Cannula, Surgical, General & Plastic Surgery 1Retractor, Self-Retaining 1Needle, Gastro-Urology 1Source, Carrier, Fiberoptic Light 1Accessories, Arthroscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253020	Strauss Surgical Resection Instruments	2026-06-04
US	K260271	Strauss Surgical cystoscope, hysteroscope and accessories Instruments	2026-03-27
US	K251652	Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo	2025-08-01
BR	80102513437	Instrumentos para Cisto-Uretroscopia Strauss Surgical	Class I
BR	80102512828	Passador de Sutura	Class I
BR	80102512829	INSTRUMENTOS ARTROSCÓPICOS	Class I
CA	94658	STRAUSS SURGICAL STRAUSS OPTIKS NASO-PHARYNGOSCOPE	Class II
CA	94662	STRAUSS SURGICAL STRAUSS OPTIKS HD LARYNGO-PHARYNGOSCOPE	Class II

American Medical Endoscopy, 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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