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CALDERA MEDICAL, INC.

USA · Neuchatel

✓ 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

8listed device types

Class I 0Class II 8Class III 0

plus 35 registration records and 24 510(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

0active device licences

1 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 States35 registration records, 24 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: CALDERA MEDICAL, INC. · CALDERA MEDICAL SARL

FDA 510(k) clearances by year

22006

12008

12009

22010

22011

12012

42013

12014

22015

12017

12018

42020

12021

12023

FDA listed device types

Cystoscope And Accessories, Flexible/Rigid 1Hysteroscope (And Accessories) 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator 1Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling 1Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Cutaneous Electrode Stimulator For Urinary Incontinence 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233500	Benesta Tissue Removal Device	2023-11-30
US	K211975	Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System	2021-11-10
US	K192811	BenestaTM Tissue Removal Device	2020-10-23

CALDERA MEDICAL, 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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