17 results · 23ms · Sources: EU EUDAMED, US FDA

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MPS ACACIA PAIN KIT

FDA 510(k)
FDA Class 2 ·General Hospital

Implant Prosthetics

FDA UDI
Preat Corporation·00842092103159·CAMLOG® Screw-Line-compatible 4.3mm Straight Mu...

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964023369·The ENDO CARRY-ON Procedure Kit contains all of...

Lumenis Pulse 120H

FDA UDI
LUMENIS LTD.·07290109145457·

TRISTAR

FDA Adverse Event
Injury ·GUIDANT·Product code MAF·April 28, 2000

TORQUE INSTRUMENT, MODEL 8500

FDA 510(k)
FDA Unclassified ·Unknown

MODIFICATION TO CD SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MINMED QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 19, 2025

HT X-DRIVE SCREW

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·August 14, 2015

POLYAXIAL DUEL CORE SCREW

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008

BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·March 13, 2018

AUTOSOFT 90

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 21, 2025

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024