43 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRILLIUM BIOPUMP PLUS, MODEL BPX80T
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE
FDA UDI
Nuvasive, Inc.·00887517973863·Pulse Spine Clamp, Small
MBA™ Titanium Subtalar Implant System
FDA UDI
Ascension Orthopedics, Inc.·10381780065517·The MBA titanium subtalar implant is cylindrica...
Subtalar MBA Implant System
FDA UDI
Smith & Nephew, Inc.·00885556865897·SUBTALAR MBA IMPLANT. 9MM
MedGyn Pessary Oval w/o support # 9
FDA UDI
MEDGYN PRODUCTS, INC.·M803050109·Oval Pessary is used to treat uterine prolapse.
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450405536·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139059·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
FDA 510(k)
FDA Class 2
·Hematology
FLUOROPERM 151-OK, PARAGON HDS 100-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 3, 2025
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 16, 2026
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Recall
Terminated
·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·April 5, 2011
MENTOR
FDA Adverse Event
Injury
·Product code FWM·May 21, 2008