17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mako Total Knee Application
FDA 510(k)
FDA Class 2
·Neurology
Micro Lamina Spreader
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896104723·Micro Lamina Spreader With Speed Lock Mini Tip
Bausch + Lomb
FDA UDI
Bausch & Lomb Incorporated·00757770436651·PICK OVAL WDW HOUS 30DEG 2/3MM
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776177256·WEISMAN-PEDS SPEC R Large . .
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197071253·Sculpo Retractor
25x300...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197071246·Deaver Retractor
25x230...
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M633301705810·PICK OVAL WINDOW HOUSE 30-DEG .66MM
PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILVER ALGINATE II WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 6, 2017
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 18, 2018
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·October 14, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 21, 2011
G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 8, 2024
G7 SCREW 6.5MM X 30MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 8, 2024
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