31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Stryker GmbH·07613154639601·Screw Marker 15,6
K2 OPAQUER powder, O-B1, 15g
FDA UDI
Yeti Dentalprodukte GmbH·EYET3201506·
Lockheed - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAMILTON-C3
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·October 17, 2008
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 2, 2013
ZNN¿¢, CMN LAG SCREW REAMER, SHORT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HAW·September 24, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014
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
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
FDA Enforcement
Class II
·Terminated·Advandx Inc·August 13, 2014
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 29, 2015