18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MONOJECT 12ML SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003223·1.6mm Pre-bent Plate, 2mm step, Right
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186879·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197044530·Cooley vascular forceps 1mm,
cross-...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197044523·Cooley vascular forceps 1mm,
20.0cm...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064033·1.6 OSA 2mm Pre-bent Right Plate Sterile Qty 2
SCHILLER
FDA UDI
SCHILLER MEDICAL·07613365900132·SpO2 sensor for MAGLIFE Serenity
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMISTEM H HA COATED STD STEM SIZE4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 12, 2018
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
RX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
DW ARTHROSCOPY FLUID MANAGEMENT DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·September 11, 2024
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015