25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle
FDA 510(k)
FDA Class 2
·General Hospital
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197535816·Kelly Retractor
Hollow...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197069717·Richardson grip Retractor 20x25mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197535823·Kelly Retractor
Hollow...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197069731·Richardson grip retractor 38x38mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197069748·Richardson grip retractor 19x51mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197069755·Richardson grip retractor 41 x 64mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197535809·Kelly Retractor
Hollow...
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CELOX RAPID GAUZE
FDA 510(k)
FDA Unclassified
·Unknown
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·June 4, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 21, 2011
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·November 20, 2017
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·November 20, 2017
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025