17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Volcano Visions PV .018 Digital IVUS Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239630·
HHM
FDA UDI
Oticon A/S·05707131288875·H110V2 TI, RITE 312 WL STG HHM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE
Tibial Ultra+ Trial Insert Size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073886·
MILLENNIUM MULTI-LEAF COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025
OSS NON-MOD PROX TIB 7CM15X150
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·June 6, 2019
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 8, 2011
AED PLUS
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 3, 2008
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-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