12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESCAPE V100
FDA 510(k)
FDA Class 2
·Cardiovascular
OSSTAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SILCONE COATED I/A 45 HANDHELD INSTRUMENT
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·May 7, 2019
OLYMPUS ESG-100, 100...120 V~,
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022
DEPUY1 GENTAMICIN CEMENT 40G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·April 23, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 29, 2011
ISOFLEX S
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
NORIAN DRILLABLE INJECT 10CC-STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code FAQ·March 25, 2003
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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024