23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPACT PIEZO P2K, POWERCARE
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304446984·
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664008536·BELLA STRONG 15-20 MM HG ARMSLEEVE DOT BAND SIZ...
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101608·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828144803·GEN4 Direct Access
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828162029·GEN4 INTERACTIVE
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Symmetry Sarot
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482054550·Symmetry® Needle Holder; Sarot; 7 3/8 in
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026158·PLATEAU Interbody, Straight, Bulleted, 10mm 22m...
EPIPHANY
FDA UDI
PANTHEON SPINAL, LLC·B528100122011022180·22MM STRAIGHT COBB SHAFT
3.2MM DRILL BIT/QC/145MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·December 28, 2020
REMSTAR PRO CFLEX
FDA Adverse Event
Injury
·RESPIRONICS INC·Product code BZD·August 23, 2021
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON·Product code KOG·May 12, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2013
PUMP IN STYLE ADVANCES BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·September 17, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 19, 2011
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