11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAP LOOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197527231·Super-Cut Gorney-Freeman Scissors
curved...
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ISOSEEDS I-125
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
AXIOM ARTIS DBA
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IZI·August 11, 2008
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024