17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RENEW LS-2
FDA 510(k)
FDA Class 2
·Dental
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004052·ELEVATOR 302 B
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004076·ELEVATOR 304 B
Implant Prosthetics
FDA UDI
Preat Corporation·00842092102930·CAMLOG® Screw-Line-compatible 3.8mm X 4.5mm Tit...
3M™ Unitek™ APC™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221237040·APC FF Clarity Ultra SL MBT L Lt 2nd Bicusp -17...
3M™ Unitek™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221287403·Clarity Ultra SL Bkt MBT L Lt 2Bicuspid -17T/2A...
SILHOUETTE
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 21, 2025
JILCO TRACTION-FLEXION CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
K-ASSAY AT-III
FDA 510(k)
FDA Class 2
·Hematology
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
SMALL ELECTRIC DRIVE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
HEX STARDRIVE SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·February 28, 2013
EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011
GURADIAN 4000 WHEEL CHAIR
FDA Adverse Event
Other
·A & E·Product code IOR·February 6, 2008
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024