Company
Teleflex Medical Europe Ltd
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 4 |
| BTC | Bag, Reservoir | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 |
| GBM | Catheter, Urethral | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LRW | Scissors, General, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers:
a) 112082050
b) 112082055
c) 112082060
d) 112082065
e) 112082070
f) 112082075
g) 112082080
h) 112082085 Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers:
a) 112080050
b) 112080055
c) 112080060
d) 112080065
e) 112080070
f) 112080075
g) 112080080
h) 112080085
i) Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers:
a) 504550
b) 504555
c) 504560
d) 504565
e) 504570
f) 504575
g) 504580
f) 504585
g) 504590 Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers:
a) 170050
b) 170055
c) 170060
d) 170065
e) 170070
f) 170075
g) 170080
h) 170085
i) 170090
j) 170095 Terminated |
BTR | K780900 |
| Jun 14, 2018 | Teleflex Medical Europe Ltd Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542
Product Usage:
general surgical scissors Terminated |
LRW | None listed |
| Apr 17, 2018 | Teleflex Medical Europe Ltd Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50
Product Usage:
for use in respiratory and anesthesia circuits to connect two or more components of a breathing sy Terminated |
BZA | None listed |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Baker Jejunostomy Tubes:
Product Code Equivalent Code
(a) 655300160 655316
(b) 655500200 655520 Terminated |
KNT | K841035 |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Simplastic Suprapubic Puncture Instruments:
Product Code Equivalent Code
(a) 650704100 551310
(b) 650704120 551312
(c) 650704160 551316
Product Usage:
RUSCH Simplastic Supr Terminated |
GBM | None listed |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Rectal Catheters;
Product Code Equivalent Code
580114 580114
Product Usage:
Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled. Terminated |
FAP | K962472 |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Latex Rebreathing Bags:
Product Code Equivalent Code
(a) 151174050 151174
(b) 153000005 153000005
(c) 153000010 153000010
(d) 153000020 153000020
(e) 153000030 153000030
(f) 153000050 153000050
(g) 21 Terminated |
BTC | None listed |
| Mar 19, 2018 | Teleflex Medical Europe Ltd Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region Terminated |
CCT | None listed |