36 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Sky Bio CAD-CAM Abutments
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
OnX - B1
FDA UDI
Sprintray, Inc.·00850039704093·Full arch provisional restoration for all-on-x ...
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPIOX ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 16, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2026
INFUSE BONE GRAFT 12 MG
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·May 1, 2014
HAMILTON-C6
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·April 14, 2026
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Recall
Open, Classified
·Foundation Medicine, Inc.·Product code PQP·March 20, 2026
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JIR·January 20, 2026
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026