FDA Medical Devices

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

Karl Storz Endoscopy

Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…

Cook Biotech, Inc.

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray dete…

FUJIFILM Healthcare Americas Corporation

Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): …

Cook Biotech, Inc.

WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsi…

Boston Scientific Corporation

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.

Boston Scientific Corporation

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

CareFusion 303, Inc.

Critical Sep 25, 2024

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Num…

B Braun Medical Inc

Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.

Boston Scientific Corporation

HAWK Advanced Hypothermia Management Set, Item Number: 59-320

Safeguard US Operating LLC

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

CareFusion 303, Inc.

HAWK Warming Grid, Item Number: 59-300

Safeguard US Operating LLC

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

MEDLINE INDUSTRIES, LP - Northfield

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for…

Boston Scientific Corporation

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Numb…

B Braun Medical Inc

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Numb…

B Braun Medical Inc

TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabi…

Innovasis, Inc

STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog …

B Braun Medical Inc

System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 72222…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W

B Braun Medical Inc

stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

Tornier, Inc

VariSoft Infusion Set, Single Use.

Unomedical A/S

Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothe…

Safeguard US Operating LLC

Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

CareFusion 303, Inc.

Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system

CareFusion 303, Inc.

ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging…

GE Healthcare GmbH

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Produc…

Medtronic Inc.

Critical Sep 25, 2024

Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry sys…

Siemens Healthcare Diagnostics, Inc.

Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and an…

SEER MEDICAL PTY LTD

Critical Sep 25, 2024

Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrume…

Beckman Coulter, Inc.

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

ROi CPS LLC

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

Cypress Medical Products LLC

ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistr…

Siemens Healthcare Diagnostics, Inc.

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

Boston Scientific Corporation

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Cypress Medical Products LLC

System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 All…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagn…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

Smith & Nephew, Inc.

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

Btt Health Gmbh

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, …

MEDLINE INDUSTRIES, LP - Northfield

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using th…

Siemens Healthcare Diagnostics, Inc.

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular…

Zimmer GmbH

Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. …

MEDLINE INDUSTRIES, LP - Northfield

Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item…

MEDLINE INDUSTRIES, LP - Northfield

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Ecc…

Sol-Millennium Medical Inc.