22 results · 22ms · Sources: EU EUDAMED, US FDA

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PANTOS, MODELS: PANTOS 16, AND PANTOS DG

FDA 510(k)
FDA Class 2 ·Dental

Life Instruments

FDA UDI
Life Instrument Corporation·M930703180100·Life L-Column Arm with Universal Attachment

Phonak

FDA UDI
Sonova AG·07613275614105·Phonak Naída B30-SP (beige)

DL950 Patient Cable

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146DL9510·

FUTURA TOPCAP NON GAMMA-2

FDA 510(k)
FDA Class 2 ·Dental

STEATHSTATION TREATMENT GUIDANCE PLATFORM

FDA 510(k)
FDA Class 2 ·Neurology

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

AFX

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·January 26, 2016

AFX SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·September 16, 2015

AFX

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·September 8, 2015

ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL-STERILE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code OVE·April 2, 2013

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·February 25, 2011

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 17, 2008

AFX SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·October 2, 2015

PERFORMER INTRODUCER

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 28, 2017

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only

FDA Enforcement
Class II ·Terminated·Copan Italia·September 15, 2021

Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the Autostainer Link 48 automated workstations operating either singly or in networked configurations.

FDA Enforcement
Class II ·Terminated·Dako North America Inc.·October 1, 2014

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016