18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PENLIGHT/SWAB HOLDER
FDA 510(k)
FDA Class 1
·General Hospital
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551199886·Scissors, curved, sharp/sharp, 13 cm
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004472·PERC DLR SPINE WAND SURGICAL DEVICE
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460002·Perc DLR Convenience Pack Inc 17 gauge 6” Crawf...
CONNECTOR
FDA UDI
Orthofix US LLC·18257200125258·STRAIGHT IMPLANT INSERTER
Sklar
FDA UDI
SKLAR CORPORATION·10649111338656·CUSHING LANDOLT SPEC 70X15MM
Action®
FDA UDI
ACTION PRODUCTS, INC.·00089904007988·Action® 2" Original Armboard Pad
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418287·Meyerding Retracor,
32 x 2...
9.1MHZ PENCIL PROBE 840
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787023800·
MYRIAN 1.4
FDA 510(k)
FDA Class 2
·Radiology
PAP-TRAY II (CATALOG #C600-2)
FDA 510(k)
FDA Class 1
·Pathology
Allofit® IT Acetabular Systems
FDA UDI
Zimmer, Inc.·00889024152441·
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·May 5, 2014
SCREW-IN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 22, 2015
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·January 15, 2014
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FPA·December 24, 2013
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018