30 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPRESS ANTI-ROTATION SPINDLES
FDA 510(k)
FDA Class 3
·Orthopedic
CPS TIB SPINDLE LT 12X37X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317397393·
BIO-KINETIX® THERMAL NITANIUM®ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707060442·.017 X .025 LOWER BIO-KINETIX® THERMAL NITANIUM...
Indus
FDA UDI
SPINEFRONTIER, INC.·00190361035695·Indus Invue MAX Symmetrical ACP, 3 Level, 75mm
Sulcus Former
FDA UDI
BICON, LLC·00813110024442·7 Series Sulcus Former
ZAVATION TAP
FDA UDI
Zavation LLC·00197157013141·TIGER 2 TAP, Ø 7.5mm, EXCELSIUSGPS
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013
54CM BIPOLAR LEAD
FDA Adverse Event
Injury
·GREATBATCH MEDICAL·Product code DTB·May 2, 2011
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·August 6, 2008
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·July 10, 2012
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
FDA Enforcement
Class I
·Terminated·Symbios Medical Products, LLC·June 12, 2013
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
FDA Enforcement
Class I
·Terminated·Symbios Medical Products, LLC·June 12, 2013
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·October 17, 2012
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021
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