18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Knotless TensionTight Button Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
FDA 510(k)
FDA Class 2
·Radiology
EX-PRESS GLAUCOMA FILTRATION DEVICE
FDA Adverse Event
Injury
·OPTONOL LTD.·Product code KYF·September 14, 2024
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVSCULAR GALWAY·Product code NIQ·October 8, 2008
BD VACUTAINER BRAND NEEDLES
FDA Adverse Event
Injury
·Product code JKA·August 5, 2011
PINNACLE 100 ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code OAE·March 10, 2026
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code KYF·August 2, 2024
WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 2, 2024
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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021