31 results · 24ms · Sources: EU EUDAMED, 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