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

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OASYS(r) System

FDA 510(k)
FDA Class 2 ·Orthopedic

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704283389·BABY RIBBON RETRACTOR 7 1/2" x 1"

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

OsteoMed

FDA UDI
OSTEOMED LLC·00845694047036·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 55mm,...

MaxFuse,VBR, 12 (D) x 14 (W) x 33 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056292·12 (D) x 14 (W) x 33 (H)

AIDI DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

FDA 510(k)
FDA Class 2 ·Hematology

UNKNOWN VALTRAC PRODUCT

FDA Adverse Event
Malfunction ·UNITED STATES SURGICAL·Product code GDW·September 29, 2011

UNKNOWN VALTRAC PRODUCT

FDA Adverse Event
Malfunction ·UNITED STATES SURGICAL·Product code GDW·September 29, 2011

UNKNOWN VALTRAC PRODUCT

FDA Adverse Event
Malfunction ·UNITED STATES SURGICAL·Product code GDW·September 29, 2011

RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

FDA Adverse Event
Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 6, 2011

CARELINK

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·October 8, 2014

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020