46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Litho 150, Cyber Ho 150
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pole Mount for use with VTI TQI Doppler, Gen 0.5
FDA UDI
VASCULAR TECHNOLOGY, INCORPORATED·00817122020584·Part Number 201455, Pole Mount for use with VTI...
Ionto Plus Small Electrode
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237901755·Iontophoresis Drug Delivery Small Kit Electrode...
Ionto Plus Small, Box of 12
FDA UDI
COMPASS HEALTH BRANDS CORP.·10853904006022·Iontophoresis Drug Delivery Electrodes
Richmar
FDA UDI
South Dakota Partners Inc.·00850030915252·Richmar Small Ionto Electrode, Box of 12
ZAVATION TAP
FDA UDI
Zavation LLC·00197157021429·MIS Tap 5.5MM
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
ACUVUE 2 BRAND CONTACT LENSES
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·June 28, 2013
UNKNOWN DEPUY INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 16, 2008
CVC KIT: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·August 3, 2011
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 2, 2026