20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114540·LOCATOR F-Tx Abutment for 3.8mm CAMLOG Connecti...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604510·FOOT EXTENSION PAD 4", 20 X 10 X 4
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110924·LOCATOR R-Tx Abutment for 3.8mm Camlog Connecti...
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825013547·Tourniquet Cuff Dual Port, Dual Bladder (Red), PLC
SONIC MODEL SO-300
FDA 510(k)
FDA Class 2
·Physical Medicine
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024377523·ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 4, 2025
AVISTA MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 10, 2025
EMAX2PLUS
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 26, 2013
CVC KIT: 2-LUMEN 15 FR X 23 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code MSD·April 7, 2011
UNK DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·July 18, 2008
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017
Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103 A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff.
FDA Recall
Terminated
·Sterilmed Inc·Product code KCY·August 8, 2008
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014