17 results · 21ms · 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.

ATLANTIS STRAUMANN BONE LEVEL ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI

N/A

FDA UDI
Tyber Medical, LLC·M695M1302160·

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776306458·Tissue Forceps 5 12" 4x5 teeth

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450723104·

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180586·Integra® Jarit® Tissue Forceps, 5-3/4", 4 x 5 T...

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

ENDO GIA ROTICULATOR 60-3.5 SULU

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·April 8, 2013

COLONCARE

FDA 510(k)
FDA Class 2 ·Hematology

EXPEDIUM SYSTEM, VIPER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

DIMENSION EXL 200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 24, 2013

PINNACLE MTL INS NEUT44IDX62OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 30, 2014

LEGEND FOOTED ATTACHMENT

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·June 16, 2011

DIMENSION EXL WITH LM

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

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015