Home›USA›KIRWAN SURGICAL PRODUCTS, LLC.

KIRWAN SURGICAL PRODUCTS, LLC.

USA · Marshfield

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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

14listed device types

Class I 7Class II 7Class III 0

plus 25 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

5active device licences

Class II 4Class III 1

21 including historic records

TWTaiwanTFDA

7valid device licences

Class I 4Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

AUAustraliaTGA ARTG

29active ARTG entries

Class I 9IIb 17Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 States25 registration records, 19 510(k), 0 PMA

Saudi Arabia5 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: KIRWAN SURGICAL PRODUCTS, LLC. · KIRWAN SURGICAL PRODUCTS, LLC · Kirwan Surgical Products LLC · Kirwan Surgical Products, LLC

FDA 510(k) clearances by year

31990

11991

11993

11994

21996

21997

11998

11999

12003

12005

32007

12010

12023

FDA listed device types

showing 8 of 14

Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Needle 1Apparatus, Electrosurgical 1Electrode, Electrosurgical 1Unit, Cautery, Thermal, Battery-Powered 1Clamp, Carotid Artery 1Instrument, Manual, Specialized Obstetric-Gynecologic 1Mallet 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231872	Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)	2023-08-25
US	K100912	DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE	2010-08-19
US	K070360	KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601	2007-08-07
SA	ME0000007155SFDAA00011	REUSABLE BIPOLAR CORD	—
SA	ME0000002385SFDAA00003	Reusable Bipolar Cable, 12 FEET (3.66M) SILICONE	—
CA	5240	MONOPOLAR ELECTRODES	Class II
CA	5595	DRILL BIT/BUR	Class II
CA	12006	BIPOLAR COAGULATORS	Class III

KIRWAN SURGICAL PRODUCTS, LLC.

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