28 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AIDI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Hader
FDA UDI
Preat Corporation·00842092155523·Hader Combo Pack. Kit contains . 2 Hader Yellow...
CONKLUSION
FDA UDI
SIGNUS Medizintechnik GmbH·04047844006535·The CONKLUSION Pedicle Screw System is a spinal...
GE
FDA UDI
Philips Ds North America LLC·00884838066274·High Resolution Wrist Coil (Receive Only)
Personalized Mobile Floss Bus Cards with Appt Reminder Mint
FDA UDI
PRACTICON, INC.·00723896009338·Dental Floss
Sklar®
FDA UDI
SKLAR CORPORATION·10649111377419·INSTR TRAY 6.875 X 4.25 X 2
ANTI-A (MURINE MONOCLONAL) SERIES 1
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 27, 2016
Sklar®
FDA UDI
SKLAR CORPORATION·30649111118740·INST TRAY 6 7/8 X 4.25 X 2 PK6
Sklar
FDA UDI
SKLAR CORPORATION·30649111004968·INSTR TRAY 67/8X 41/4 X 2 PK12
First Choice Partial Ulnar Head Implant
FDA UDI
Smith & Nephew, Inc.·00885556826539·FIRST CHOICE HEAD 17.5-STEM 5.5
STRYKER T4 HYTREL (R) TOGAS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025
CARESCAPE MONITOR B850
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·May 10, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 3, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
EDWARDS LIFESCIENCES·Product code LWR·August 5, 2008
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025