27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ES™ TROCHANTERIC NAIL, LEFT, 12.5mm x 42cm x 125 GOLD
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036343·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721322·House Alligator Ear Forceps 3" (7.5cm) shaft, s...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197508308·RZ Tebbet Breast Retractor
190x25...
PGA
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code GAM·December 13, 2019
POLYPROPYLENE
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code GAW·September 27, 2019
HASKAL TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POLYPROPYLENE
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code GAW·September 27, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
LONG NAIL KIT R2.0, TI, RIGHT 11X340MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 28, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 26, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 16, 2014
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
BACT/ALERT MP - 419744
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 5, 2019
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013