Panels › Ear, Nose, Throat › Product code EOB · Class 2
Nasopharyngoscope (Flexible Or Rigid)
Regulation 874.4760
5510(k)s in 12 months (163 all time)
1recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in EOB
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 | 0 |
| Vision-Sciences, Inc. | 15 | 2 |
| Olympus Medical Systems Corp. | 8 | 0 |
| Acclarent, Inc. | 4 | 0 |
| Pentax of America, Inc. | 4 | 0 |
| 3nt Medical , Ltd. | 3 | 0 |
| Ambu A/S | 3 | 0 |
| Karl Storz Endoscopy | 1 | 2 |
| Olympus America, Inc. | 3 | 0 |
| Olympus Corporation of the Americas | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 1993 | K932988 | ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY Smith & Nephew Richards, Inc. | EOB |
| May 17, 1993 | K930931 | NASAL/PARANASAL ENDOSCOPE Storz Instrument Co. | EOB |
| Jan 15, 1993 | K925421 | ENDOSHEATH Vision-Sciences, Inc. | EOB |
| Oct 6, 1992 | K921244 | DISPOSABLE PROTECTIVE SHEATH Vision-Sciences, Inc. | EOB |
| Sep 4, 1992 | K920439 | OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE Omega Universal Technologies, Ltd. | EOB |
| Jul 1, 1992 | K921707 | PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 Pentax Precision Instrument Corp. | EOB |
| Oct 31, 1990 | K902683 | SCOPESCRUBBER(TM) Healthtek Microsurgical, Inc. | EOB |
| Apr 10, 1990 | K900176 | ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES Machida, Inc. | EOB |
| Jan 26, 1990 | K896297 | FLEXIBLE NASOPHARYNGOSCOPE Jedmed Instrument Co. | EOB |
| Nov 17, 1989 | K895245 | FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE Optimed Technologies, Inc. | EOB |
| Aug 10, 1988 | K882744 | EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM Effner, Inc. | EOB |
| Jan 4, 1988 | K874215 | ENDOSCOPES FOR SINUS SURGERY Richards Medical Co., Inc. | EOB |
| Feb 10, 1987 | K864821 | AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 Reichert-Jung, Inc. | EOB |
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