16 results
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28ms
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Sources: EU EUDAMED, US FDA
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 70mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025316·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609348·ALLEN, STERIS-AMSCO 4" DELUXE
Anti-TCRa/b-APC (Clone REA652)
FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934133893·REA652 recognizes the human alpha/beta T cell r...
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126476·
RADIOMED SOURCE
FDA 510(k)
FDA Class 2
·Radiology
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
FDA Enforcement
Class III
·Terminated·Advanced Sterilization Products·December 11, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·March 17, 2016
ST104 TRANSPORT OBS 7-2010
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 26, 2013
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 14, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 21, 2008
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 26, 2021
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014