22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIOECO
FDA 510(k)
FDA Class 2
·Dental
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197508896·Super-Cut RZ Gorney Facelift Scissors
gerade...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197527217·Super-Cut RZ Gorney Facelift Scissors
gerade...
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
FDA 510(k)
FDA Class 2
·Cardiovascular
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYSPINE SCREW, UNKOWN SIZE OR TYPE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·August 17, 2020
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ASR XL ANATOMIC HEAD SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code NKB·March 24, 2020
EASYSPINE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code NKB·July 9, 2019
ARCHITECT B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025
cobas 8000 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
STEM: AMISTEM H HA COATED LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 4, 2019