18 results · 19ms · Sources: EU EUDAMED, 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