Company ยท US
Ultracell Medical Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2001. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2001 | K012196 | ULTRACELL ABSORBENT STICK Ultracell Medical Technologies, Inc. | HOZ |
| Dec 17, 1997 | K972634 | ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. | GDY |
| Dec 17, 1997 | K972633 | ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. | HOZ |
| Dec 9, 1997 | K973083 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| Nov 24, 1997 | K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) Ultracell Medical Technologies, Inc. | FEB |
| Nov 18, 1997 | K973085 | ULTRACELL PACKING WITH SLEEVE Ultracell Medical Technologies, Inc. | EMX |
| Oct 1, 1997 | K972635 | ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. | GBX |
| Apr 21, 1997 | K970328 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| Aug 15, 1995 | K950647 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| Apr 17, 1995 | K950373 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 17, 1995 | K950372 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 17, 1995 | K950370 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 13, 1995 | K950659 | ULTRACELL RETRACTOR COVERS Ultracell Medical Technologies, Inc. | GDY |
| Feb 17, 1995 | K945554 | EPISTAXIS BALLOON CATHETER WITH PACKING Ultracell Medical Technologies, Inc. | EMX |
| Jan 19, 1995 | K945555 | NASAL SPLINT Ultracell Medical Technologies, Inc. | LYA |
| Jan 18, 1995 | K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER Ultracell Medical Technologies, Inc. | EMX |
| Mar 19, 1993 | K923922 | SURGICAL SPEARS Ultracell Medical Technologies, Inc. | HOZ |
| Feb 12, 1993 | K924542 | NASAL-SINUS PACKING Ultracell Medical Technologies, Inc. | EMX |
| Feb 1, 1993 | K920357 | ULTRACELL EAR WICK Ultracell Medical Technologies, Inc. | KCN |
| Nov 30, 1992 | K920358 | ULTRACELL NASAL PACKING Ultracell Medical Technologies, Inc. | EMX |
| Sep 15, 1992 | K920353 | ULTRACELL INSTRUMENT WIPE Ultracell Medical Technologies, Inc. | HEP |
| Aug 6, 1992 | K920356 | SURGICAL SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Aug 6, 1992 | K920355 | SPECIALTY SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Aug 5, 1992 | K920354 | OPHTHALMIC SPONGES Ultracell Medical Technologies, Inc. | HOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2003 | Ultracell Medical Technologies Lasik Spears Blunt (5)
Catalog #: U/S32-100 Terminated |
HOZ | K923922 |
| Jan 30, 2003 | Ultracell Medical Technologies PVA Foam Surgical Spears
Catalog #: OASIS0525 Terminated |
HOZ | K923922 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultrakleen KSponge II Spears
Catalog #: K20-5012 Terminated |
HOZ | K923922 |
| Jan 30, 2003 | Ultracell Medical Technologies Rhinocell Nasal 6.0 x 1.5 x 2.0 w/Airway
Catalog #: BMPNP601520A Terminated |
EMX | K920358 |
| Jan 30, 2003 | Ultracell Medical Technologies Otocell Ear Wick 15mm
Catalog #: BMPEW0915 Terminated |
KCN | K920357 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultacell Diamond Knife Cleaning Block 15mm
Catalog #: 40462 Terminated |
MDZ | None listed |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell Ear Wick 9mm DIA x 24 mm
Catalog #: 30310-C Terminated |
KCN | K920357 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell Ear Wick Fenestrated 9mm DIA x 15mm
Catalog #: 30305-C Terminated |
KCN | K920357 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric)
Catalog #: 30301-C Terminated |
KCN | K920357 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell Ear Wick 9mm DIA x 15 mm
Catalog #: 30300-C Terminated |
KCN | K920357 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell Classic Anatomical Nasal Packing w/Tube (pediatric)
Catalog # 10126-CT Terminated |
EMX | None listed |
| Jan 30, 2003 | Ultracell Medical Technologies 8.0 cm Nasal Classic Anatomical Nasal w/tube
Catalog #:10120-CT Terminated |
EMX | K920358 |
| Jan 30, 2003 | Ultracell Medical Technologies Ultracell 8.0 cm Nasal Packing w/tube
Catalog #:10110-CT Terminated |
EMX | K920358 |