10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Keeler TonoCare Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
Border-Lock® Upper Tray #43
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015813·Dental impression tray, single-use
HEARTWAY POWER MOBILITY SCOOTER, S11
FDA 510(k)
FDA Class 2
·Physical Medicine
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
FDA 510(k)
FDA Class 2
·Dental
OT ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·August 14, 2019
BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·June 21, 2013
NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·July 8, 2011
ACCU-CHEK ADVANTAGE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·September 30, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018