13 results · 28ms · Sources: EU EUDAMED, US FDA

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HERCULITE ULTRA

FDA 510(k)
FDA Class 2 ·Dental

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 25, 2025

EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 31, 2018

12/14 ARTICUL 40MM M SPEC+8.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 29, 2013

MICRO RECIPROCATING SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·April 28, 2011

ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code JCT·July 23, 2008

BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH

FDA Adverse Event
Malfunction ·SYNTHES TUTTLINGEN·Product code HXP·July 16, 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

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018