24 results · 28ms · Sources: EU EUDAMED, 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