24 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPSY DIGIT S BIOPSY SL
FDA 510(k)
FDA Class 2
·Radiology
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267574·
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304554085·
SimplyGo Mini
FDA UDI
Respironics, Inc.·00606959033825·SimplyGo Mini with Standard Battery, IKK.
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003938·75 V2 SM 22ID STRAIGHT NO HG
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795002481·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024647558·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494060·
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
FDA 510(k)
FDA Class 2
·Orthopedic
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·May 30, 2019
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
FDA Enforcement
Class II
·Ongoing·ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY·March 26, 2025
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
ECLIPE TREATMENT PLANNING SYSTEM
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS, INC.·Product code MUJ·May 9, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 24, 2011
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 23, 2019
COMP RVRS SHLDR GLNSP +6 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 23, 2019
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 23, 2019
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 23, 2019