28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HANAROSTENT BILIARY (NNN)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BiPAP A30
FDA UDI
Respironics, Inc.·00606959039353·BiPAP A30 Ventilatory Support System, France
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390851671·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026032·microSelectron Transfer Tube for Metal Needles ...
CLEARFIX RIGID STERNAL FIXATION Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089436842·
DISPOSABLE BENDING CANNULA PR-233Q
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 26, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 30, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/44MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·September 23, 2014
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·June 2, 2011
STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 20, 2019
MAZOR X SYSTEM
FDA Adverse Event
Death
·MAZOR ROBOTICS LTD·Product code OLO·March 28, 2025
RENAISSANCE SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code HAW·March 24, 2025
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNS·March 26, 2024
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 30, 2016
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·May 29, 2024