17 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
XN CAL
FDA 510(k)
FDA Class 2
·Hematology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045117·PrimaLIF LLIF PEEK Implant, 7mm X 18mm X 45mm, ...
COSMED MICROQUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AGC DA2000 KN TIB BRG 71/75X8
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 9, 2026
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 15, 2008
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025
TINBN VANGUARD INT PS ANAT FM R 75MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·June 4, 2025
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025
BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·September 19, 2022
Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
FDA Enforcement
Class II
·Terminated·XTANT MEDICAL INC·February 6, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024