16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
FDA 510(k)
FDA Class 1
·General Hospital
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551067154·Suction Tube, cylindrical, dia. 0.5 mm
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756059749·CAST BOOT
Arena-C
FDA UDI
SPINEFRONTIER, INC.·00190361023074·Arena-C HA Straight 5mm 11x17 IBFD
PN 32G X 4MM BENELUX
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 11, 2021
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
PN 32G X 4MM BENELUX
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 23, 2021
ABBOTT COMMANDER PPC
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JQW·October 21, 2008
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
PERFORATOR DRIVER W/HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·July 3, 2013
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 19, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012