28 results · 22ms · Sources: EU EUDAMED, US FDA

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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