21 results
·
28ms
·
Sources: EU EUDAMED, US FDA
AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
A.R.T.™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868005541·
Cutimed® Sorbact®
FDA UDI
BSN medical GmbH·07392130002263·CUTIMED SORBACT GEL STERILE 8"X10" GREEN 5 US
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108109·JAFFE NEEDLE HOLDER CURVED
XiVE®
FDA UDI
Dentsply Implants Manufacturing GmbH·07392532223440·Twist Drill crestal D3.4
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197477413·Whitehead mouth gag
130mm, 5"
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295149255·CORE CASE 1 INSTRUMENT CASE COMPLETE
ResolutionMD
FDA 510(k)
FDA Class 2
·Radiology
ACUSON Juniper Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 9, 2024
MERIT HEMOSTASIS VALVE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 19, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·September 23, 2011
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·July 31, 2013
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026