FDA Medical Devices

Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software …

Osteotec Limited

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

Philips North America

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

Philips North America

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounti…

Implant Direct Sybron Manufacturing LLC

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

Philips North America

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Cels…

INSTITUT GEORGES LOPEZ

Upgrade to MR 7700 Model Number (REF): 782130;

Philips North America

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Philips North America

Blood/MacConkey Biplate 100/PK, Product Number R02049

Remel, Inc

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Phasor Health, LLC

Critical Aug 6, 2025

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 v…

Hamilton Medical AG

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Philips North America

Strep Selective II Agar, Product Number R01859

Remel, Inc

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Philips North America

Critical Aug 6, 2025

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

Philips North America

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

Fresenius Kabi USA, LLC

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions …

Volcano Corp

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 72202…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

HeartSine Technologies Ltd

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved …

FUJIFILM Healthcare Americas Corporation

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

Philips North America

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Philips North America

Intera 3.0T Quasar Dual Model Number (REF): 781150;

Philips North America

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KI…

MEDLINE INDUSTRIES, LP - Northfield

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software M…

Medtronic, Inc.

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

Beckman Coulter Inc.

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P

MEDLINE INDUSTRIES, LP - Northfield

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

Stryker Corporation

Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Olympus Corporation of the Americas

Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El…

Olympus Corporation of the Americas

Biofinity XR Toric Contact Lens

CooperVision, Inc.

SIGNA Architect

GE Medical Systems, LLC

Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Mod…

Medtronic, Inc.

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

MEDLINE INDUSTRIES, LP - Northfield

Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus…

Olympus Corporation of the Americas

Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

SIGNA Architect AIR

GE Medical Systems, LLC

Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…

Olympus Corporation of the Americas

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…

Olympus Corporation of the Americas

Azurion 7 M20. Fluoroscopic X-Ray System.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

CooperSurgical, Inc.

Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

Bridge to Life Ltd

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Versi…

Encore Medical, LP

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

ICU Medical, Inc.

Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra appl…

Medtronic, Inc.

Critical Jul 23, 2025

i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

Intersurgical Inc

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devic…

Waismed Ltd.