13 results · 30ms · 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.

IFS LASER SYSTEM

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

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large

SUPRASPERM SYSTEM

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

LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

OMNIGUIDE BEAMPATH FIBER AND ADAPTER

FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010

ADVANTAGE SERIES 26 OBS 10/04

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 23, 2013

UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 1, 2011

QUICKSITE LV

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

DIMENSION EXL 200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013

PINNACLE SECTOR II CUP 60MM

FDA Adverse Event
Injury ·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018

Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366

FDA Recall
Terminated ·Boston Scientific Corporation·Product code LJT·February 10, 2004

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