510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Teleflexmedical, Inc.

Durham, NC, US

Teleflexmedical, Inc. appears in FDA device records in Durham, NC. FDA records list 64 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
64
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 64

FDA records hold 64 510(k) clearances for Teleflexmedical, Inc. between 1985 and 2024. The busiest year on record is 2014, with 12. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Teleflexmedical, Inc., by decision year
YearClearances
19854
19862
19881
19922
20071
20081
20091
20101
20115
20122
20134
201412
20159
20166
20174
20183
20194
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232469Rüsch Latex Gold Foley CatheterEZLSubstantially Equivalent
K212077Teleflex Rusch SoftSimplastic Foley CathetersEZLSubstantially Equivalent
K192324Sheridan Spiral-Flex Endotracheal TubesBTRSubstantially Equivalent
K182847Hudson RCI Voldyne Volumetric ExerciserBWFSubstantially Equivalent
K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKODSubstantially Equivalent
K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent CatheterGBMUnknown
K181852Percuvance Percutaneous Surgical SystemGEISubstantially Equivalent
K173280Neonatal ConchaSmart Breathing CircuitsBZESubstantially Equivalent
K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCWSubstantially Equivalent
K161770Rusch Silicone Foley CatheterEZLSubstantially Equivalent
K162522UltraCath Continuous Nerve block CatheterBSOSubstantially Equivalent
K162989Rusch Simplastic Foley CathetersEZLSubstantially Equivalent
K162242Comfort Flo Humidification SystemBTTSubstantially Equivalent
K162396SILK Surgical SutureGAPSubstantially Equivalent
K161075Arrow Epidural Catheter KitCAZSubstantially Equivalent
K153089'cottony' II TAPE, PLEDGETSGATSubstantially Equivalent
K153010Hudson RCI AquaPak Sterile Prefilled NebulizersCAFSubstantially Equivalent
K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEELGATSubstantially Equivalent
K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEMGEISubstantially Equivalent
K150603Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal TubeBTRSubstantially Equivalent
K152081Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierFZPSubstantially Equivalent
K143581Arrow Epidural Catheter KitCAZSubstantially Equivalent
K142103CUFF PILOT, SURE SEALBSKSubstantially Equivalent
K142153HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15MLCAFSubstantially Equivalent
K141888RUSCH ENDOBRONCHIAL TUBESCBISubstantially Equivalent
K150438Force Fiber OrthoTape sutureGATSubstantially Equivalent
K143469SOFTECH Plus ETCO2 CannulaCCKSubstantially Equivalent
K143299Percuvance(R) Percutaneous Surgical SystemGCJSubstantially Equivalent
K142777Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierFZPSubstantially Equivalent
K141214AQUAPAK NEBULIZER ADAPTORS/RESERVOIRSCAFSubstantially Equivalent
K141939TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLETBTRSubstantially Equivalent
K142138ISO-GARD MASKCBNSubstantially Equivalent
K140205PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMCACSubstantially Equivalent
K140197PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMCACSubstantially Equivalent
K141353HUDSON RCI AQUAPAK HUMIDIFIER ADAPTORBTTSubstantially Equivalent
K133439PILLING ESOPHAGEAL BOUGIESFATSubstantially Equivalent
K132415RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBEBTRSubstantially Equivalent
K132946SOFTECH PLUS ETC02 CANNULACCKSubstantially Equivalent
K133173RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SETJOHSubstantially Equivalent
K132729ISO-GARD MASKCBNSubstantially Equivalent
K132362WECK EFX ENDO FASCIAL CLOSURE SYSTEMOCWSubstantially Equivalent
K122235RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SETJOHSubstantially Equivalent
K123176ISO-GARD CLEARAIR MASKCBNSubstantially Equivalent
K130043PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMCACSubstantially Equivalent
K121796WECK REUSABLE OBTURATORGCJSubstantially Equivalent
K121380WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORTGCJSubstantially Equivalent
K112554TRANSRADIAL ARTERY ACCESS DEVICESDYBSubstantially Equivalent
K112456ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORTGCJSubstantially Equivalent
K111900NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETERMSDUnknown
K111117CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...MSDUnknown

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain