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TOOLS FOR SURGERY, LLC

USA · Stony Brook

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

7listed device types

Class I 4Class II 3Class III 0

plus 8 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States8 registration records, 4 510(k), 0 PMA, 23 excluded

Brazil1 confirmed, 12 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: TOOLS FOR SURGERY, LLC · SoPlus: Orthopaedic & Surgical power tools for bone surgery

FDA 510(k) clearances by year

22004 · K040109

12022 · K220218

12025 · K242901

FDA listed device types

Surgical Instruments, G-U, Manual (And Accessories) 1Syringe, Irrigating (Non Dental) 1Catheter, Irrigation 1Dilator, Rectal 1Staple, Implantable 1Rod, Colostomy 1Tubes, Gastrointestinal (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242901	ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)	2025-01-10
US	K220218	Siren SGT	2022-05-18
US	K040109	HEMORRHAGE OCCLUDER PIN	2004-03-25
BR	10314800102	INSTRUMENTAL NÃO ARTICULADOS CORTANTES SOPLUS	Class II

TOOLS FOR SURGERY, LLC

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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