FDA Medical Devices

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Beaver-Visitec International, Inc.

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Vortex Surgical Inc.

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF…

Philips Ultrasound, LLC

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial…

Ferndale Laboratories, Inc.

Material Processing Laser Products

SHENZHEN ATOMSTACK TECHNOLOGIES

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, …

Sheathing Technologies Inc

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-…

CareFusion 303, Inc.

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900…

Medtronic Neuromodulation

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: …

Zimmer, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: …

Zimmer, Inc.

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

ICU Medical, Inc.

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diod…

Howmedica Osteonics Corp.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: …

Zimmer, Inc.

Critical Dec 31, 2025

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-…

Cook Incorporated

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Microbiologics Inc

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

Intuitive Surgical, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: …

Zimmer, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: …

Zimmer, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: …

Zimmer, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: …

Zimmer, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: …

Zimmer, Inc.

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

ICU Medical, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: …

Zimmer, Inc.

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

AGFA Healthcare Corp.

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Microbiologics Inc

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Microbiologics Inc

R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for tran…

Cook Incorporated

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: …

Zimmer, Inc.

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Cepheid

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

Low Dec 24, 2025

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Zimmer Surgical Inc

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 1…

Mindray DS USA, Inc. dba Mindray North America

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

PATH

Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (s…

Myofunctional Research Company USA

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Abbott Laboratories

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

AVID Medical, Inc.

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product D…

Rocket Medical Plc

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE Healthcare GmbH

Halyard, EP LAB PK. Catalog Number: ESJH009-03.

AVID Medical, Inc.

Low Dec 24, 2025

Cardiosave Rescue

Datascope Corp.

Critical Dec 24, 2025

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012…

GE Medical Systems China Co., Ltd.

Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 5…

DSAART LLC

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

AVID Medical, Inc.

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

AVID Medical, Inc.