16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568250·CoRoent Ant TLIF PEEK, 9x13x34mm 0°
Sklar®
FDA UDI
SKLAR CORPORATION·10649111074738·CARMALT SPLINTER FCP CVD 4 1/4
PASR/QUIETNITE
FDA 510(k)
FDA Class 2
·Dental
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNK - SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·July 29, 2011
EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWB·June 27, 2013
M2A 38MM MOD HEAD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 22, 2014
COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017