9,954 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VCA Lite
FDA UDI
Pce, Inc.·00860009492905·5.3 cc Vaginal Cream Applicator in a 7-pack can...
VCA Lite
FDA UDI
Pce, Inc.·00860009492912·5.3 cc Vaginal Cream Applicator 3-Pack. Three ...
IDEIA PCE CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
VAR (VORTRAN Automatic Resuscitator) with Extension
FDA UDI
VORTRAN MEDICAL TECHNOLOGY 1, INC·10637320050124·The VAR® device is a unique single-patient-use,...
HTI Plastics, a Division of PCE Inc.
FDA registration
HTI Plastics, a Division of PCE Inc.·1 product·🇺🇸 United States
PCE Pen Panel Transmitter Box
FDA UDI
NEOCOIL, LLC·00856181003411·The NeoCoil Patient Communication and Entertain...
GLUMA DESENSITIZER SINGLE DOSE 40X1 PCE
FDA UDI
Kulzer GmbH·J014660018540·Agent, tooth bonding resin
GLUMA COMFORT BOND+DESENSIT.SD 40X1 PCE.
FDA UDI
Kulzer GmbH·J014660056640·Agent, tooth bonding resin
PATIENT CONTROLLED EPIDURAL
FDA Adverse Event
Malfunction
·Product code MEA·April 25, 2018
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 7, 2022
DAVINCI 5
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 25, 2026
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC MEXICO·Product code NDN·July 5, 2022
DAVINCI 5
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 18, 2026
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Enforcement
Class II
·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017
DAVINCI 5
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 25, 2026
DAVINCI 5
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 7, 2026
SIMPLEX P - CE TOBRA FD 10-PK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·January 14, 2010
Siemens
FDA UDI
Ws Audiology Usa, Inc.·04046355386679·Siemens ACCU. BLISTER PACK 13 1 PCE. Hearing a...
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code NDN·September 27, 2012
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 18, 2019