20 results · 22ms · Sources: EU EUDAMED, US FDA

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First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837087791·

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

FDA 510(k)
FDA Class 2 ·Ophthalmic

UNIMAX VERESS NEEDLE

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

VERSYS FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LPH·February 25, 2016

LINER 28 MM I.D.

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code KWY·August 21, 2023

GREENLIGHT HPS BPH FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 30, 2013

REMANUFACTURED BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·June 8, 2011

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 5, 2008

CPT HIP SYSTEM FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JDI·October 1, 2024

MULTIPOLAR BIPOLAR CUP

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code KWY·July 1, 2024

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

Precise Digital Accelerator Delivery of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 26, 2012

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

FDA Enforcement
Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024