24 results · 21ms · Sources: EU EUDAMED, 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