14 results · 22ms · 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.

N LATEX RF KIT

FDA 510(k)
FDA Class 2 ·Immunology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111095597·F.O.MILLER BLADE AMER-STYLE #1

HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

FDA 510(k)
FDA Class 2 ·General Hospital

PNEUMOPERITONEUM INSUFFLATION NEEDLE

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

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 13, 2025

VERCISE GEVIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 24, 2023

PATIENT SAFETY NET

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

PATIENT SAFETY NET

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·April 22, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

SUMMIT BASIC PRESS FIT SZ 2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LWJ·July 7, 2008

ENDOPATH ETS FLEX

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 17, 1997

AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

FDA Enforcement
Class II ·Terminated·Vision Rt Inc·January 14, 2015

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