13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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