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Baxter Healthcare of Puerto Rico LLC

USA · Aibonito

✓ 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

180listed device types

Class I 42Class II 91Class III 41unclassified 6

plus 586 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 3Class II 7

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

0valid device licences

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 States586 registration records, 10 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Manufacturer names merged into this page: STERIS ISOMEDIX PUERTO RICO, INC. · MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO · BD Puerto Rico LLC · Baxter Healthcare of Puerto Rico LLC · U.S.S.C. PUERTO RICO, INC · MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Same-named companies — This database also contains companies with near-identical names: BD Puerto Rico LLC, Plastic Materials of Puerto Rico, Inc., STRYKER PUERTO RICO, LLC., Terumo Puerto Rico LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11988

11990

21997 · K972303

31999 · K992264

32001 · K013377

FDA listed device types

showing 8 of 180

Electrosurgical, Cutting & Coagulation & Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Washer, Bolt Nut 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K013377	BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS	2001-12-20
US	K012425	BIOMEDICS UV MULTIFOCAL	2001-10-12
US	K003136	OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS	2001-01-06
BR	10349000226	AGULHA DE ACESSO E INSUFLACAO VERSASTEP	Class II
BR	10349000624	KIT DE ACESSÓRIOS DE ELETRODO DF4- MODELO 6056M	Class I
BR	10349000311	GRAMPEADOR MULTIUSO RELIAMAX	Class II

Baxter Healthcare of Puerto Rico 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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