16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446820543·SPECIAL, EMPOWR KNEE, EXTENDED BOSS 2DEG VAR VA...
EarQ
FDA UDI
Oticon A/S·05707131353726·G40 S, MINIRITE T 312 2.4G C044 EARQ
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
FDA 510(k)
FDA Class 2
·Physical Medicine
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
FDA 510(k)
FDA Class 2
·Neurology
STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 11, 2024
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 27, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·July 2, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 11, 2023
UNK - CAGE/SPACERS: CERVIOS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code ODP·May 11, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025