20 results · 23ms · 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.

REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

FDA Adverse Event
Injury ·SHASER INC·Product code ONF·May 21, 2021

LUMENA FH HAIR REMOVAL SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197056601·SCHNIDT-SAWTELL Tonsil Seizing Forceps 185mm,...

CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018

AFFIITY CP CENTRIFUGAL BLOOD PUMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

VITALAB DIRECT BILIRUBIN REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MAXZERO

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022

CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018

PULSE GEN MODEL 103

FDA Adverse Event
Injury ·CYBERONICS INC·Product code LYJ·May 31, 2013

HEARTSTART MRX- EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011

ITREL 3

FDA Adverse Event
Malfunction ·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code LGW·August 28, 2008

BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

BD MAXZERO¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021

MAXZERO NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015