12 results · 20ms · 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.

CABLE, TRANSDUCER, MODEL 2400GN

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PRISMASATE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 27, 2024

NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code MQV·April 29, 2013

MAXCEM ELITE

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·May 10, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·July 29, 2008

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 25, 2024

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 21, 2024

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

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

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016