29 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 28, 2023
MedStream
FDA UDI
MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472106749·DRESSING CHANGE CUSTOM
Ophthlamic Speculum
FDA UDI
KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856002531·PRE CONTOURED CP ROD 5.5 x 7cm NON-BROACHED
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383556286·"An absorbent paper points is an endodontic pap...
UP - Vehicle - 380-55230 - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal
PHYSICA FIXED TIBIAL PLATE #3
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HRY·February 13, 2023
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGITRON IEC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 17, 2014
ALLURA XPER FD10
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·August 4, 2011
Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.
FDA Recall
Terminated
·Vistakon·Product code LPL·April 20, 2009
E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·October 13, 2009
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 18, 2013
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
FDA Enforcement
Class II
·Terminated·Aspen Surgical Products, Inc.·August 28, 2013