20 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS SLALOM PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Premier Crown Removers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783010169·CROWN REMOVER HANDLE W/CAP
TruForm
FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008623·Micro Forceps, Round Handle, curv DD platform t...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008647·Micro Forceps, Round Handle, curv DD platform t...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018950·TITANIUM MICRO FORCEPS ROUND HANDLE CURVED DIAM...
SCANLAN® Titanium Neuro Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159036275·Micro Suture Tying Fcp, RH, Gerald taper, curv ...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008630·Micro Forceps, Round Handle, curv DD platform t...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018943·TITANIUM MICR FCEPS RND HNDL CURV PLATFM D-DUST...
SCANLAN® Titanium Neuro Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159012040·Micro Suture Tying Fcp, RH, Gerald taper, curv ...
BD 50ML SYRINGE- LUER LOK TIP
FDA Adverse Event
Injury
·BECTON DICKINSON & COMPANY·Product code FMF·May 13, 2020
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 16, 2024
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 28, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 12, 2014
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025