19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMBRYOGLUE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Cetro America Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler
FDA UDI
CETRO AMERICA INC·00852519007052·Ultrasound Transducer for Kranzbüler FC6/8, FS...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107776·HA PEEK EVOS Straight, ,15mmx11mmx 30mm , FLAT ...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313459·STABILITY TRIAL CUP Ø36 + 15
STANDARD TRIAL HUM...
S & T AG
FDA registration
S & T AG·10 products·🇨🇭 Switzerland
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810310150·Dwyer Calcaneal Guide, 31mm x 15mm
ELECSYS THYROGLOBULIN CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 29, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 29, 2015
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC.·Product code LNM·October 30, 2015
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 4, 2016
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024