36 results · 31ms · Sources: EU EUDAMED, 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