27 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Preat
FDA UDI
Preat Corporation·00842092169223·Preci-Clix Lab Tool Kit; . kit contains 1 Clix ...
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751012980·Inline Straight Ratcheting Handle
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 30, 2024
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code DTB·December 4, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
OSS DIAPHYSEAL SEGMENT 7CM WITH SCREWS POROUS COATED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 15, 2012
OSS INTERLOK BOWED IM STEM WITH SCREW 11MM X 150MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 15, 2012
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2011
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 30, 2024
COBALT¿ XT DR MRI SURESCAN¿
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code LWS·April 19, 2023
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
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