28 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Hader
FDA UDI
Preat Corporation·00842092112731·Hader Red Riders- Increased
GE
FDA UDI
Philips Ds North America LLC·00884838065628·High Resolution Wrist Coil (Receive Only)
Lieberman Speculum
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896109162·Lieberman Speculum Temporal Approach 26 Millime...
Personalized Mobile Floss Bus Cards Mint
FDA UDI
PRACTICON, INC.·00723896009314·Dental Floss
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365107603·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111377310·TRAY COVER FOR 10-1753
Sklar
FDA UDI
SKLAR CORPORATION·30649111240601·TRAY COVER FOR 10-1753 PACK/12
Sklar®
FDA UDI
SKLAR CORPORATION·30649111101971·COVER FOR 10-1753 - PACK OF 6
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EXEL SECURETOUCH PTP SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013
PROFEMUR MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·August 7, 2008
INNOVA 2000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 10, 2011
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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