15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PATIENT CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFYLE
FDA UDI
Stryker GmbH·04546540251824·Countersink, Stryker-Shaft
Batrik Brush/Yel/BD10+ 12.5mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007987·Brush/Yellow/BD 12.5mm/BL 50mm/OL 80cm - Asymet...
ITOTAL FAMILY REUSABLE INSTRUMENT TRAY
FDA UDI
Conformis, Inc.·00850268007446·NA
LEONE SPA
FDA UDI
LEONE SPA·08033707000945·MICRO SECT SCREWS U S/STEEL 12mm
BIPOLAR COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
FDA 510(k)
FDA Class 1
·Dental
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 30, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
CVC KIT: 2-LUMEN 15 FR X 23 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code MSD·April 7, 2011
DELTEC COZMO INSULIN PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·July 17, 2008
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014
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