32 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NPseal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A1c-Cellular
FDA UDI
STRECK, INC.·00844509000945·A liquid control appropriate for immunoassay an...
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111528·HALO, 1203-5 VEST SMALL, COOLMAX LINER, 1211-1 ...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41432111300·Titanium TLIF Spacer, 32 x 11 x 13mm, 0 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40432111300·PEEK TLIF Spacer, 32 x 11 x 13mm, 0 deg
CORTAC®
FDA UDI
PMT CORPORATION·00650551064527·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 30 CO...
IMAGE DIAGNOSTICS, INC
FDA UDI
IMAGE DIAGNOSTICS, INC.·00850061871367·IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC ...
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
FDA 510(k)
FDA Class 2
·Orthopedic
PREMIUM
FDA 510(k)
FDA Class 2
·Dental
CORTAC®
FDA UDI
PMT CORPORATION·00650551089094·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 30 CO...
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
PROG VALVE RIGHT ANGLE
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·November 13, 2020
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·October 23, 2008
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 8, 2011
FINELINE II STEROX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·July 8, 2013
BD BACTO AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JSK·January 27, 2021
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·January 1, 2020
Tapered Screw-Vent MTX Model TSVTB11
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·December 27, 2017
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
FDA Enforcement
Class II
·Terminated·Silk Road Medical Inc·March 3, 2021
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025