24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FETALTROL
FDA 510(k)
FDA Class 2
·Hematology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964018921·Endo Carry-On Procedure Kit
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I
Natus
FDA UDI
XLTEK·00382830020916·P32-STIM POD 1 (E-H)-20' (CR)
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746103544·BRACKET NARROW TWIN MAND RIGHT/MAX LEFT CUSPID ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450123263·
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00885074269313·LP12AAACABAABBABAAAAAAAALP12 MONITOR-DEFIB
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148844·Straight Implant Trial 25mm x 9mm x 11mm
O-LAS OPHTHALMIC PHOTODISRUPTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
CANNULATED STRAIGHT DRIVER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWT·February 3, 2022
X3 TRIATHLON CS INSERT #5 9MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 13, 2013
UNKNOWN PRODUCT - STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·February 16, 2011
SJM MASTERS SERIES VALVE EXPANDED CUFF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, INC.·Product code LWQ·February 26, 2008
Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONGE PREWASH 18" X 18" XRD (1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x 124" (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41" X 69" MEDIUM ( 1) MAYO STAND COVER REINFORCED ( 1) GOWN SURG XLGE REINFORCED TOWEL & WRAP AAMIIII ( 1) BLADE SURGICAL STAINLESS STEEL# 10 (2) LIGHT SHIELD ( 1) CAUTERY PENCIL ROCKER SWITCH ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) UTILITY BOWL BLUE 16oz ( 1) TOWELS ABSORBENT 15" X 20" ( 1) SOLUTION SURGICAL DURAPREP 6ML Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016