20 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

FDA 510(k)
FDA Class 2 ·Radiology

AMERICAN SURGICAL COMPANY, LLC

FDA registration
AMERICAN SURGICAL COMPANY, LLC·5 products·🇺🇸 United States

ELECTRONIC STETHOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUBDURAL STRIP ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·February 3, 2005

PROFEMUR(R) MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·MICROPORT ORTHOPEDICS INC.·Product code LWJ·November 3, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

URETEX TO2 URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·May 17, 2013

CAPTURE-R READY-SCREEN 3 TEST WELLS

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·April 3, 2008

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK-SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Death ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 7, 2012

Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management

FDA Enforcement
Class I ·Terminated·Teleflex Medical·June 26, 2019

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025