20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C3 Wave System
FDA 510(k)
FDA Class 2
·General Hospital
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304677333·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083966·TC Olsen Hegar Needle Holder
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083980·STRATTE TC Needle holder,serrated
200mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197084000·STRATTE TC needle holder, serrated
230mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083973·TC Olsen Hegar Needle Holder
straig...
PALOMAR ASPIRE LASER PLATFORM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEARL DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 15, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 20, 2013
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
Malfunction
·DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INP·July 27, 2011
COMP NLK SCR 3.5HEX 4.75X35 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP RVS CNTRL 6.5X30MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·June 28, 2018
COMP NLK SCR 3.5HEX 4.75X30 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
Fixed Core Wire Guide
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 21, 2018
Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024