21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Locator Overdenture Implant System
FDA 510(k)
FDA Class 2
·Dental
6PW - CPRotector® ONE Deluxe - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA
Tasso Mini
FDA UDI
Tasso Inc.·00850038691141·
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIONEW-IV
FDA 510(k)
FDA Class 2
·Cardiovascular
TIBIAL NAIL, STANDARD T2 TIBIA 10X315 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 22, 2012
PEN NDL 32GA 4MM 14BAG 700CASE JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 28, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
BD MICRO FINE PLUS INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 23, 2021
BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 25, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·October 27, 2014
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025