11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393461·LOOP KIT
SENTRYSUITE PRODUCT LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
OPTIMA
FDA 510(k)
FDA Class 2
·Physical Medicine
UNKNOWN REJUVENATE HIP NECK
FDA Adverse Event
Injury
·STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI·Product code MEH·January 4, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2010
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
E-POLY 36MM +3 MAXROM LINER SZ23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MAY·May 1, 2018
REGENEREX/RINGLOC+ LIMITED 52MM SIZE 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 1, 2018
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024