Company ยท US
TELEFLEX LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
151recalls (1 in 12 months)
145recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 128 |
| BTS | Tube, Bronchial (W/Wo Connector) | 9 |
| CAH | Filter, Bacterial, Breathing-Circuit | 6 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 |
| CAZ | Anesthesia Conduction Kit | 3 |
| DYB | Introducer, Catheter | 3 |
| EFQ | Gauze/Sponge, Internal | 2 |
| GAD | Retractor | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| FZP | Clip, Implantable | 1 |
| KAL | Retractor, Ent | 1 |
| KOD | Catheter, Urological | 1 |
| MGB | Device, Hemostasis, Vascular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2025 | K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear P Teleflex Incorporated | BTR |
| Jun 21, 2016 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set Teleflex, Inc. | CAZ |
| Mar 27, 2015 | K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET Teleflex, Inc. | BSO |
| Nov 24, 2014 | K141940 | CONCHASMART COLUMN Teleflex, Inc. | BTT |
| Sep 24, 2014 | K140556 | CONCHASMART BREATHING CIRCUIT Teleflex, Inc. | BTT |
| Mar 6, 2014 | K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN Teleflex, Inc. | BTT |
| Feb 21, 2013 | K123974 | PERCUTANEOUS INTRODUCER KIT Teleflex, Inc. | DYB |
| Jun 20, 2012 | K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET Teleflex, Inc. | CAZ |
| May 16, 2012 | K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER Teleflex, Inc. | CAZ |
| Jun 19, 1986 | K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER Teleflex, Inc. | DYB |
| May 20, 1986 | K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET Teleflex, Inc. | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | TELEFLEX LLC Brand Name: Pilling Wecksorb
Product Name: Pilling Wecksorb Neurosponges (Cotton)
Pilling Wecksorb Neurosponge Strips (Cotton)
Model/Catalog Number:
200100
200101
200102
200103
200104
200105
200106
20 Open, Classified |
EFQ | K791871 |
| Jul 5, 2023 | TELEFLEX LLC Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor Open, Classified |
GAD | None listed |
| Jul 5, 2023 | TELEFLEX LLC Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor Open, Classified |
GAD | None listed |
| Jul 5, 2023 | TELEFLEX LLC Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor Open, Classified |
KAL | None listed |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040 Open, Classified |
BTR | K993786 |
| Jun 29, 2023 | TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030 Open, Classified |
BTR | K993786 |
| Jun 29, 2023 | TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025 Open, Classified |
BTR | K993786 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035 Open, Classified |
BTR | K931164 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090 Open, Classified |
BTR | K931163 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085 Open, Classified |
BTR | K931163 |
| Jun 29, 2023 | TELEFLEX LLC Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080 Open, Classified |
BTR | K931163 |
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