FDA Medical Devices

American Contract Systems Hand Pack convenience kit

American Contract Systems, Inc.

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6…

BioFire Diagnostics, LLC

American Contract Systems Biopsy Drape Pack convenience kit

American Contract Systems, Inc.

Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300

Baxter Healthcare Corporation

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Luminex Corporation

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation Syst…

Integra LifeSciences Corp.

IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care pro…

Philips North America Llc

IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care prof…

Philips North America Llc

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

GE Medical Systems, LLC

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appro…

Beckman Coulter Mishima K.K.

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

Angiodynamics, Inc.

SlideView VS200 slide viewer,

EVIDENT SCIENTIFIC INC

Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU U…

Medivance Inc.

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles:…

BioFire Diagnostics, LLC

Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices ar…

Boston Scientific Corporation

BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Au…

Becton Dickinson Infusion Therapy Systems, Inc.

ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the …

Radiometer Medical ApS

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

LINK BIO CORP

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product …

B Braun Medical Inc

Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only

Abbott Medical

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jeju…

Avanos Medical, Inc.

Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

Abbott Medical

TourniKwik Tourniquet Set (CFN 79012)

Medtronic Perfusion Systems

Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative to…

Siemens Medical Solutions USA, Inc

Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pum…

B Braun Medical Inc

Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump …

B Braun Medical Inc

BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, s…

Embecta Corp.

Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and admin…

Siemens Medical Solutions USA, Inc

Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow im…

Securitas Healthcare LLC

Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

Abbott Medical

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Beckman Coulter Inc.

Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic an…

Siemens Medical Solutions USA, Inc

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

Alcon Research LLC

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ …

B. Braun Medical, Inc.

Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Abbott Medical

Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Stryker Sustainability Solutions

Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Mo…

B. Braun Medical, Inc.

Cascade IOMAX Cortical Module, REF: 190296-200

Cadwell Industries Inc

Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator

Canadian Hospital Specialties Ltd.

Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…

B. Braun Medical, Inc.

Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

Abbott Medical

Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalo…

B. Braun Medical, Inc.

Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication …

B. Braun Medical, Inc.

Critical Jul 24, 2024

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure …

Baxter Healthcare Corporation

Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catal…

B. Braun Medical, Inc.