86 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Z-MED Z-MED II
FDA 510(k)
FDA Class 2
·Cardiovascular
Likorall™ overhead lift
FDA UDI
Liko AB·00887761979468·Overhead track patient lifting/transfer system
ArgenZ HT+ 98x14 A3
FDA UDI
ARGEN CORPORATION, THE·D818122012·Dental porcelain/ceramic restoration kit
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193110097·HA PEEK EVOS Straight, ,12mmx9mmx 22mm , BICONV...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1220100·Breaker, Extended Tab
Class A Outdoor 21 - 16 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620121·Class A Outdoor 21 - 16 Poly White
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961220120·TC Dissecting forceps ADSON
tungst...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152239·12F x 2.0cm MiniSPC Low Profile Suprapubic Cath...
DIGITAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES LOW PROFILE NEURO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BD SYRINGE
FDA Adverse Event
Injury
·BD·Product code FMF·May 16, 2013
MAQUET HCU30 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWC·September 19, 2014
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·May 24, 2011
LIKORALL OVERHEAD LIFT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FSA·January 20, 2026
ONYX AVM
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·May 1, 2015
ONYX AVM
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·May 1, 2015
ONYX AVM
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·May 1, 2015
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 17, 2019
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
(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