Company
Unomedical
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)
46recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
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) |
|---|---|---|---|
| Jun 19, 2015 | Unomedical As Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset
Used in combination with infusion pumps for continuous subcutaneous infusion of medication. Terminated |
FPA | K120395 |
| Nov 7, 2014 | Unomedical As SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; Su Terminated |
FPA | K041545 |
| Nov 7, 2014 | Unomedical As Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, Terminated |
FPA | K002138 K972135 |
| Nov 7, 2014 | Unomedical As Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Confor Terminated |
FPA | K120872 K972135 |
| Nov 7, 2014 | Unomedical As AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 Terminated |
FPA | K120872 K972135 |
| Nov 7, 2014 | Unomedical As Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Deta Terminated |
FPA | K041545 |
| Nov 7, 2014 | Unomedical As Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusio Terminated |
FPA | K120872 K972135 |
| Nov 4, 2009 | Unomedical Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only:
Product codes: 734-E, 734MM. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only:
Product number 733-E. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only.
Product code: 725-E, Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E.
Packaged under the name of Hospitak, McKesson. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E;
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM.
Packaged under the name of Hospitak and McKesson Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E.
Packaged under the name of Evergreen, Hospitak and McKesson. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM.
Packaged under the name of Evergreen, Hospitak, and McKesson. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM.
Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612.
Packaged under the name of Dynarex, Evergreen, Hospitak and Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM.
Packaged under the name of Dynarex and Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203.
Packaged under the name of Dynarex, Evergreen, Mada and H Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206.
Packaged under the name of Dynarex, Evergreen, Mada and Hospita Terminated |
BTM | K873286 |
| Dec 8, 2004 | Unomedical, Inc Drger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Unomedical REF 962MM, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 8026, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 1450, Face Ten Mask w/ Aerosol Tubing 60'', Oxygen Tubing 7'' & Connector, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 1011, IPPB Ventilator Circuit, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 903-E, IPPB Ventilator Circuit, manufactured by Unomedical, Inc of McAllen , Texas and assembled in Mexico Terminated |
BZA | None listed |
| Dec 8, 2004 | Unomedical, Inc Hospitak, REF 903-GM, IPPB Circuit Exhalation Valve & Nebulizer Circuit Universal 4'' Length with Adapter, manufactured by Unomedical, Inc of McAllen , Texas and assembled in Mexico Terminated |
BZA | None listed |