16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994455703·CASE 3123001 ATL SD SCREW CADDY LID
Likorall™ overhead lift
FDA UDI
Liko AB·00887761979529·Overhead track patient lifting/transfer system
LEONE SPA
FDA UDI
LEONE SPA·08033707002895·COIL SPRINGS MEMORIA W/WOUND ENDS CLOSED
CONMED
FDA UDI
Conmed Corporation·20653405009440·BIPOLAR ELECTROSURGICAL FORCEPS, HANDSWITCHING ...
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
FDA 510(k)
FDA Class 2
·Physical Medicine
ROCKWOOD CLAVICLE PINS
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069684469·COMPASS GPS V2.5 VA package
NA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·December 4, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 21, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MAF·June 14, 2011
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 23, 2022
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017