16 results · 28ms · Sources: EU EUDAMED, US FDA

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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