16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOMEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943000108·
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664222727·ULTRA SHEER 30-40 MM HG THIGH W/LACE BAND CLOSE...
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 26, 2014
RINGLOC ACETABULAR LINER 28MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 13, 2011
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022
GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016
GMK PS TIBIAL INSERT SIZE 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015