100 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRYOMEGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950023141·TIP ONLY FOR YANKAUER SUCTION 1" 2 1/2CM
Preat
FDA UDI
Preat Corporation·00842092111987·Preci Post Blue Reamer
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108018·HA PEEK EVOS Straight, ,6mmx8mmx 30mm , FLAT 0...
Alliant Biotech
FDA UDI
MEDISURGE LLC·G6112201020060·Symmetric Total Knee Femoral Component Size 6 Left
Symmetric TK Femoral Component
FDA UDI
SIGNAL MEDICAL CORPORATION·B0462201020060·Symmetric TK Femoral Component 6LT
LIFESHIELD ADDITIVE PIERCING PIN
FDA 510(k)
FDA Class 2
·General Hospital
MEDICAL DEPOT POWER NEB 1
FDA 510(k)
FDA Class 2
·Anesthesiology
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 26, 2026
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
OLYMPUS SURGMASTER ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code GEI·May 19, 2011
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 7, 2008
PRIMATRIX 18 MM DISC
FDA Adverse Event
Injury
·TEI BIOSCIENCES INC·Product code KGN·January 17, 2024
BD UNIVIA¿ WHITACRE SPINAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·January 7, 2022
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
CATH GUIDE 6F MB2 110CM Z2 CATHETER Z26MB2A Z2 6F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MB2A
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·October 10, 2006