72 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MYCOPLASMA SUPPLEMENT G
FDA 510(k)
FDA Class 1
·Microbiology
RMO
FDA UDI
Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT
SILENT NIGHT V
FDA 510(k)
FDA Class 2
·Anesthesiology
KIMBERLY-CLARK INTRODUCER KITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUPERION INDIRECT DECOMPRESSION SYSTEM
FDA Adverse Event
Injury
·VERTIFLEX INC.·Product code NQO·November 20, 2020
ARCHITECT C8000
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·June 28, 2022
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·April 30, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 8, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. The product is intended for coagulation of soft tissues in orthopedic, spinal and neuorsurgical applications.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code GXD·April 13, 2010
Stryker Instruments, SmartPump Tourniquet System, Report Printer Kit, REF 5920-012-000, Rx only, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. Provides a record of a tourniquet procedure and may be included in a patient's medical records.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KCY·April 13, 2010
Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet Pump, REF 5920-010-000, Rx only, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KCY·April 13, 2010
Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code GFA·June 13, 2011
Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code MDM·May 27, 2011
Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HRX·February 3, 2011
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
FDA Recall
Terminated
·Alden Optical·Product code HQD·July 3, 2018
Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HRX·February 3, 2011
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
FDA Recall
Terminated
·Alden Optical·Product code HQD·July 3, 2018
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023