13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
FDA 510(k)
FDA Class 2
·Orthopedic
HairCheck-DT (PCP)
FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809870046·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
HARMONIC ACE 36 CM
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005
MODIFICATION TO PROFILE -II
FDA 510(k)
FDA Unclassified
·Unknown
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 9, 2013
INFANT WARMER HEATER ASSEMBLY
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·April 6, 2011
VENTAK PRIZM 2 DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018