18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAXX(R) XD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·03596010038814·REPLACEMENT HEAD MED WT STAINLESS
...
Bernafon
FDA UDI
Bernafon AG·05711584004579·CT9 CPX, VC PS MAC CANTEO 9
Axiom® Interpleural Anesthesia
FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651114180·Interpleural Sump, Two Lumens, Round, Silicone,...
MAXCUT CARBIDE BUR (10/pk) FG 700-L
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114181·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448708·
Orthoquest
FDA UDI
Young Innovations, Inc.·00840326401187·Cutanium 27° D-Form 016X022
POWDER FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ULTRAGUIDE MR-GUIDE 3000
FDA 510(k)
FDA Class 2
·Radiology
GMK PRIMARY FIXED TIBIAL INSERT SIZE 3 17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·November 14, 2014
GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 5, 2017
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025