18 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
FDA 510(k)
FDA Class 2
·General Hospital
#4- Dissector, Side, Small, 1.7mm Cup
FDA UDI
KATALYST SURGICAL LLC·00840096203806·
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376074177·Polyaxial Screw, 7.2 mm x 80 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856084483·POLYAXIAL SCREW, 7.2mm X 80mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856086814·POLYAXIAL REDUCTION SCREW, 7.2mm X 80mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856085633·SACRAL POLYAXIAL SCREW, 7.2mm X 80mm
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023393·
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376077970·Polyaxial Reduction Screw, 7.2 mm x 80 mm
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BEHRING COAGULATION SYSTEM, MODEL BCS
FDA 510(k)
FDA Class 2
·Hematology
Crescendo Meniscal Insert PS 17mm Size 0
FDA UDI
AMPLITUDE SAS·03701089525350·
BD PRECISIONGLIDE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 21, 2021
BD NEEDLE 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·January 18, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 21, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·July 10, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014