56 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814237·GENUMEDI PT SILVER L VI
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043144·2.0mm, Locking Reconstruction Plate, 5x16 Hole,...
LEONE SPA
FDA UDI
LEONE SPA·08033707011101·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 26
HOSKIN SUTURE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896073395·HOSKIN SUTURE FORCEPS TITANIUM
BD SAFE-CLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 26, 2020
SEASPINE SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 16, 2026
BD SAFE-CLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 3, 2020
INFUSE BONE GRAFT 12 MG
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·May 1, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
NEEDLE CLIPPING DEVICE SAFE CLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 3, 2021
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·June 21, 2023
PIE PAK Models: P2HC-A, P2HC-S, P2HC
FDA Recall
Open, Classified
·Edermy LLC·Product code KPL·January 14, 2026
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026