23 results · 20ms · Sources: EU EUDAMED, US FDA

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O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

FDA 510(k)
FDA Class 2 ·Ophthalmic

Zavation

FDA UDI
Zavation LLC·00842166180673·Guidewire

Zavation

FDA UDI
Zavation LLC·00842166189232·AWL A-O ATTACHMENT

Mini Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109218·DB BKT MINI MS UL CEN 018 T+12 A+5 R=0

Integrity Orthopaedics

FDA UDI
Integrity Orthopaedics, Inc·00860013905941·Tendon Seam™ Magazine - 8 Anchor

BIRMINGHAM HIP

FDA UDI
Smith & Nephew, Inc.·03596010504647·BIRMINGHAM HIP SHORT ALIGNMENT PIN

Integrity Orthopaedics

FDA UDI
Integrity Orthopaedics, Inc·00860009782235·Integrity Orthopaedics Anchor Array

ORTHOPANTOMOGRAPH OP 3D Pro

FDA UDI
PaloDEx Group Oy·06430035872732·

Rampart One Lumbar Interbody Fusion Device

FDA UDI
SPINEOLOGY INC.·M7404901002·Rampart One Standard Spacer

MIRACLE SUCTION,MINI KIT

FDA UDI
DiaDent Group International·08806383524346·Multifunctional Mirror with Suction

BIPOLAR PENCIL, MODEL 3901-002, 3900-002

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAKO LIPASE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Truliant

FDA UDI
Exactech, Inc.·10885862604781·

PORTEX LINE DRAW PLUX W/ DRY LITHIUM HEPARIN AND FILTER-PRO

FDA Adverse Event
Injury ·SMITHS MEDICAL, INC.·Product code JKA·June 17, 2014

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 17, 2010

URETEX SUPPORT PP KIT X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·December 13, 2012

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·May 8, 2024

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·June 26, 2024

OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

FDA Enforcement
Class II ·Ongoing·Osteomed, LLC·December 15, 2021