24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Intraluminal Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
AGC Tradition Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304002470·
HHM
FDA UDI
Oticon A/S·05707131282828·H110V2, BTE 13 WL 100 SIL HHM
electrodeCUR
FDA UDI
COSMAN MEDICAL, LLC·08132500164134·Electrode 15cm, 10mm Tip, 22G
Ni-Lock® Anterior Cervical Plate System
FDA UDI
Spine Wave, Inc.·10840642102901·Plate 22mm 1 Level
electrodeCU
FDA UDI
COSMAN MEDICAL, LLC·08132500161614·Electrode 15cm, 10mm Tip, 22G
N/A
FDA UDI
Smith & Nephew, Inc.·00817470009019·15 DEG. PICK
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510220·Threaded Fixation Pin, ø3mm x 220mm
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·May 30, 2018
PULMOTRACK 5050 WHOLTER, MODEL 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
GAMMAPLAN
FDA 510(k)
FDA Class 2
·Radiology
LCCS
FDA UDI
LCCS Products Limited·04895233602222·Single-use RF Cannula
MENTOR SILTEX CONTOUR PROFILE HIGH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 3, 2020
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 6, 2013
STANDARD INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·June 29, 2011
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·August 29, 2008
MENTOR SILTEX CONTOUR PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·August 1, 2018
MENTOR SILTEX CONTOUR PROFILE HIGH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·April 1, 2019
XCELA
FDA Adverse Event
Malfunction
·PFM MEDICAL CPP SA·Product code LJT·November 7, 2023
Biograph mMR. Model Number: 10433372.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025