31 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RHEAD RADIAL HEAD EXTENDED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776304218·Supercut Knight Nasal Scs 6.75"
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304443310·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780178910·Integra® Jarit® Knight Nasal Scissors, 6-1/4", ...
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780429623·Universal Block Tray
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260226·UNIVERSAL BLOCK TRAY
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197058551·Button-end Probe
Ø1mm, ...
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800113904736·VICEROY Rod - 5.5 (D)5.5x(L)180mm
SIMPLICITY DISPOSABLE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
A-WEAR
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 16, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 8, 2022
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 12, 2026
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 26, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 6, 2022
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013
2008T HEMODIALYSIS SYS WITH CDX
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 17, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
BATTERY OSCILLATOR II FOR BPL II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·February 20, 2024
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025