13 results · 21ms · Sources: EU EUDAMED, US FDA

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FLOWER BONE SCREW SET

FDA 510(k)
FDA Class 2 ·Orthopedic

EXCELLA II SPINAL SYSTEM MODEL EC2-00

FDA 510(k)
FDA Class 2 ·Orthopedic

PRECISE CARBON FIBER TABLE TOP, MODEL 11-999

FDA 510(k)
FDA Class 2 ·Radiology

IMP TM 4.7MM MTX FULL, 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

COCR HEAD, M, ø 36/0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·April 11, 2024

CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 10.0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·April 11, 2024

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDF·June 10, 2011

AUTOGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

IMP TM 4.7MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

IMP TM 6.0MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

G7 LONGEVITY NEUTRAL 36MM F

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 1, 2024

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