13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECICE Trauma Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
MAKO SURGICAL CORP.·00848486020477·ACETABULAR REAMER ¿ 48mm
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290600·Denovo general purpose dental molar band - Mand...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044884·Unitek(TM) Molar Band General Purpose Narrow Re...
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
FDA 510(k)
FDA Class 2
·Radiology
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
SYNCHRON LX 20 PRO SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 2, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
TFNA FEM NAIL Ø10 R 125° L320 TIMO15
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018
10MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
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