22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDS Calculus Softener TURBO CR
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569967·CoRoent Ant TLIF Ti, 12x13x34mm 0°
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580303266144·3Fr 400mm Catheter, Guide with obturator
Tripod Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233403·
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258644073·
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010155·Pinnacle .022 MC(0T) LR3 0T 3A 0O (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112103·Pinnacle .022 MC(0T) LR3 0T 3A 0O (10PK) PINNACLE
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008329·Votion .022 MC(0T) LR3 0T 3A 0O (10PK)
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114015·Votion .022 MC(0T) LR3 0T 3A 0O (10PK) VOTION
Marquis
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730012555·Marquis MBT 022 LR3 Rx 0 Tor +3 Ang (10PK)
MULTIX Impact C
FDA 510(k)
FDA Class 2
·Radiology
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 7, 2024
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 25, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
IM REAMER, AO FITTING BIXCUT Ø9,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·July 12, 2013
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018