21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPIRUS MEDICAL SURGICAL INSTRUMENT
FDA 510(k)
FDA Class 1
·General Hospital
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 42mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024999·
Symmetry Gerald
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139509·Symmetry® Bipolar Forceps; Gerald Bayonet; High...
VenaOne, Single Device
FDA UDI
Precision Medical Products, Inc.·00194832000342·
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331100482·Gerald Bipolar Bayonet Forceps, 7-1/2" (19.0 cm...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links
ELECSYS B-CROSSLAPS CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CT PERFUSION 2
FDA 510(k)
FDA Class 2
·Radiology
CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·January 17, 2018
CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·January 17, 2018
COULTER® ACT¿ 5DIFF AUTOLOADER (AL)
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 26, 2013
EXCEL BARIATRIC BED FRAME
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 8MM MQC
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWX·August 9, 2016
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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