23 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828132107·GEN4 DIGITAL
NexxZr™ / W-98-22-UT-C300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139467·
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828109079·GEN4 DIGITAL
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 21, 2025
N LATEX LP(A)
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO RELIEF BRIEF
FDA 510(k)
FDA Class 1
·Physical Medicine
LINER: MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 30, 2022
LINER: MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 6, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2013
60" EVOLUTION MEDIUM VAC STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·September 19, 2014
ACT 5DIFF CP
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·May 25, 2011
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·February 18, 2015
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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021