14 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C

FDA 510(k)
FDA Class 2 ·General Hospital

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604855·BERCHTOLD B810, B710 3" SOFTCARE

SYRINGE 50ML LL TIP 1ML

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·July 7, 2024

SYRINGE 50ML LL TIP 1ML

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·July 25, 2024

NA

FDA UDI
STRYKER CORPORATION·07613327052367·Cannula, Automatic Valve, Stopcock, without Tro...

TRAY ADAPTERS, MULTIPLE

FDA 510(k)
FDA Class 2 ·Radiology

ACTION AF-1 WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

ATLAS II VR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

METRX

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK MFG·Product code LXH·May 6, 2011

SP2 IM ROD 400MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 21, 2008

Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024