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Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Phasix

FDA UDI
Davol Inc.·00801741161223·Phasix ST Mesh with Echo 2 Positioning System, ...

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193114354·HA PEEK EVOS Straight, ,15mmx11mmx 26mm , FLAT ...

666 - Certi-Strips - Woven - Fingertip - 10/Unit

FDA UDI
Certified Safety Manufacturing, Inc.·00766588100159·666 - Certi-Strips - Woven - Fingertip - 10/Unit

Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 210003 218503 L210003 210004 218504 L210004 210005 218505 L210005 210006 218506 L210006 210007 218507 L210007 210015 218516 L210008 210016 218518 L210009 210017 218519 L210010 210018 218520 L210011 210019 218521 L210012 210020 218523 L210013 210023 218524 L210014 210024 218525 L210015 210025 218526 L210016 210026 218527 L210017 210027 218528 L210018 210028 218529 210029 210030

FDA Recall
Terminated ·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003

Anatomic Abutment H4mm L6mm

FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190010928·

Anatomic Abutment H4mm L6mm

FDA UDI
NOGA MEDICAL PRODUCTS LTD·07290118141419·Anatomic Abutment H4mm L6mm

Surgical Face Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ETHICON RETICULATING LINEAR CUTTER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY CUSTOMER RESPONSE CENTER·Product code GAG·November 17, 1998

TENDRIL SF

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013

SAPIEN XT TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPV·March 13, 2026

MEDTRONIC IPG

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·July 17, 2019

MEDTRONIC IPG

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·July 17, 2019

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

FDA Enforcement
Class II ·Terminated·Pfm Medical Inc·December 17, 2014