Home›USA›BLACK & BLACK SURGICAL, INC.

BLACK & BLACK SURGICAL, INC.

USA · Tucker

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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

46listed device types

Class I 37Class II 9Class III 0

plus 51 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 11Class II 2

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

5 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

40active ARTG entries

Class I 35IIa 4Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States51 registration records, 4 510(k), 0 PMA, 13 excluded

Brazil13 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BLACK & BLACK SURGICAL, INC. · BLACK AND BLACK SURGICAL

FDA 510(k) clearances by year

12008 · K072124

12016 · K161722

12017 · K170629

12024 · K240188

FDA listed device types

showing 8 of 46

Dilator, Catheter 1Rasp 1Scissors, Surgical Tissue, Dental 1Saw, Nasal 1Clamp 1Handle, Scalpel 1Applier, Hemostatic Clip 1Dressing, Wound, Occlusive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240188	Vitruvian Liposaber	2024-09-13
US	K170629	VITRUVIAN INFILTRATION PUMP	2017-06-22
US	K161722	VITRUVIAN ULTIMATE ASPIRATOR	2016-07-26
BR	80690340046	INSTRUMENTAL CIRÚRGICO ARTICULADO CORTANTE COM CERÂMICA BLACK & BLACK	Class I
BR	80690340009	INSTRUMENTAL CIRÚRGICO ARTICULADO CORTANTE BLACK & BLACK	Class I
BR	80690340011	CÂNULA PARA LIPOASPIRAÇÃO BLACK & BLACK	Class I

BLACK & BLACK SURGICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies