Ultracell Medical Technologies, Inc.
North Stonington, CT, US
Ultracell Medical Technologies, Inc. appears in FDA device records in North Stonington, CT. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 13 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Ultracell Medical Technologies, Inc. between 1992 and 2001. The busiest year on record is 1995, with 8. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 5 |
| 1993 | 3 |
| 1995 | 8 |
| 1997 | 7 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | HOZ | Substantially Equivalent | |
| K972634 | ULTRACELL SUCTION SPONGE | GDY | Substantially Equivalent | |
| K972633 | ULTRACELL SUCTION SPONGE | HOZ | Substantially Equivalent | |
| K973083 | ULTRACELL NEURO SPONGES | HBA | Substantially Equivalent | |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | FEB | Substantially Equivalent | |
| K973085 | ULTRACELL PACKING WITH SLEEVE | EMX | Substantially Equivalent | |
| K972635 | ULTRACELL SUCTION SPONGE | GBX | Substantially Equivalent | |
| K970328 | ULTRACELL NEURO SPONGES | HBA | Substantially Equivalent | |
| K950647 | ULTRACELL NEURO SPONGES | HBA | Substantially Equivalent | |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | GDY | Substantially Equivalent | |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | GDY | Substantially Equivalent | |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | GDY | Substantially Equivalent | |
| K950659 | ULTRACELL RETRACTOR COVERS | GDY | Substantially Equivalent | |
| K945554 | EPISTAXIS BALLOON CATHETER WITH PACKING | EMX | Substantially Equivalent | |
| K945555 | NASAL SPLINT | LYA | Substantially Equivalent | |
| K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K923922 | SURGICAL SPEARS | HOZ | Substantially Equivalent | |
| K924542 | NASAL-SINUS PACKING | EMX | Substantially Equivalent | |
| K920357 | ULTRACELL EAR WICK | KCN | Substantially Equivalent | |
| K920358 | ULTRACELL NASAL PACKING | EMX | Substantially Equivalent | |
| K920353 | ULTRACELL INSTRUMENT WIPE | HEP | Substantially Equivalent | |
| K920356 | SURGICAL SPONGES | GDY | Substantially Equivalent | |
| K920355 | SPECIALTY SPONGES | GDY | Substantially Equivalent | |
| K920354 | OPHTHALMIC SPONGES | HOZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0489-03 | Lasik Spears Blunt (5) Catalog #: U/S32-100 | Sterility of the device is compromised | Terminated | ||
| Z-0488-03 | PVA Foam Surgical Spears Catalog #: OASIS0525 | Sterility of the device is compromised | Terminated | ||
| Z-0487-03 | Ultrakleen KSponge II Spears Catalog #: K20-5012 | Sterility of the device is compromised | Terminated | ||
| Z-0486-03 | Rhinocell Nasal 6.0 x 1.5 x 2.0 w/Airway Catalog #: BMPNP601520A | Sterility of the device is compromised | Terminated | ||
| Z-0485-03 | Otocell Ear Wick 15mm Catalog #: BMPEW0915 | Sterility of the device is compromised | Terminated | ||
| Z-0484-03 | Ultacell Diamond Knife Cleaning Block 15mm Catalog #: 40462 | Sterility of the device is compromised | Terminated | ||
| Z-0483-03 | Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C | Sterility of the device is compromised | Terminated | ||
| Z-0482-03 | Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C | Sterility of the device is compromised | Terminated | ||
| Z-0481-03 | Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric) Catalog #: 30301-C | Sterility of the device is compromised | Terminated | ||
| Z-0480-03 | Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-C | Sterility of the device is compromised | Terminated | ||
| Z-0479-03 | Ultracell Classic Anatomical Nasal Packing w/Tube (pediatric) Catalog # 10126-CT | Sterility of the device is compromised | Terminated | ||
| Z-0490-03 | 8.0 cm Nasal Classic Anatomical Nasal w/tube Catalog #:10120-CT | Sterility of the device is compromised | Terminated | ||
| Z-0478-03 | Ultracell 8.0 cm Nasal Packing w/tube Catalog #:10110-CT | Sterility of the device is compromised | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain