22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TITAN TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530181·
Ormco
FDA UDI
ORMCO CORPORATION·00889989014136·EDGW BRKT MED TW 018
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115018·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828117487·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828160780·GEN4 INTERACTIVE
STRONGBACK
FDA UDI
STRONGBACK MOBILITY USA, LLC·07640176290183·- Transport wheelchair
- Seat width: 18”/45 cm
...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20030180·1.5mm Cortex Screw, 1.5 Hex, Self-Tapping, 18mm
KineMatch® PFR System
FDA UDI
Kinamed, Inc.·00818720011035·PATELLA SIZER AND DRILL GUIDE, 36/39mm
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 8, 2025
V500, SAVINA AND VENTILATORS OF EVITA FAMILY
FDA Adverse Event
Other
·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·March 13, 2013
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·February 28, 2011
RADIESSE
FDA Adverse Event
Injury
·BIOFORM MEDICAL, INC.·Product code LMH·February 25, 2008
BONE PLATE 246 MM LENGTH 8 HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·March 23, 2017
2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·November 10, 2014
Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.
FDA Recall
Terminated
·Stryker Imaging·Product code LMB·August 3, 2009
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026