22 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Oculus-SA Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112793·BARRON VACUUM PUNCH 8.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ring probe (2021) 90°, 30 x 36mm
Device
EU MDR
·
Eu Md Class 2a
·Varian Medical Systems, Inc.·On the market·26 countries
Ring probe (2021) 90°, 26 x 32 mm
Device
EU MDR
·
Eu Md Class 2a
·Varian Medical Systems, Inc.·On the market·26 countries
Ring probe (2021) 90°, 30 x 36 mm, for needle usage
Device
EU MDR
·
Eu Md Class 2a
·Varian Medical Systems, Inc.·On the market·26 countries
UNKNOWN PROGRIP MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·May 20, 2024
UNK - INSERTION INSTRUMENTS: TRAUMA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 29, 2021
BD VENFLON INTRAVASCULAR CATHETER 20 G X 1
FDA Adverse Event
Injury
·BD·Product code FOZ·October 13, 2014
64 CONTACT PLATINUM CONFORMAL 4 SEP LEADS
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code GZL·October 16, 2008
HD 15 ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IYO·June 28, 2013
PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 8, 2025
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·April 14, 2022
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 2, 2021
DRIVESHAFT FOR SCREWDRIVER 90
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·October 28, 2021
UNK - CONSTRUCTS: HUMERAL NAIL
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDS·July 6, 2022
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014