13 results · 26ms · 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.

KALAZAR DETECT

FDA 510(k)
FDA Class 1 ·Microbiology

Safco Surgical Length Bur

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310234833·Safco surgical length bur, #2 round RA, 5-pack

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120234831·Carbide, round, rosehead, fast cutting, green ring

MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 2, 2019

DERMABOND ADVANCED

FDA Adverse Event
Injury ·ETHICON, INC.·Product code MPN·March 27, 2013

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2011

CIBA VISION MEMORY LENS

FDA Adverse Event
Malfunction ·CIBA VISION CORP.·Product code HQL·April 2, 2008

ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

AGENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·May 16, 2024

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024