53 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES PATIENT SPECIFIC PLATE
FDA 510(k)
FDA Class 2
·Dental
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
FDA 510(k)
FDA Class 2
·Orthopedic
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code NLM·May 3, 2013
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 26, 2020
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2019
BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 1, 2023
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 28, 2024
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·May 21, 2013
PFC CVD 10MM SZ3
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 3, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 25, 2024
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2020
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 2, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 14, 2024
BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 15, 2022
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 14, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 14, 2023