Company ยท US
Mill-Rose Laboratory
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1998. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 11 |
| GEN | Forceps, General & Plastic Surgery | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 |
| FCL | Forceps, Biopsy, Non-Electric | 2 |
| FDI | Snare, Flexible | 2 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 |
| FCK | Instrument, Biopsy, Suction | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FDX | Endoscopic Cytology Brush | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KNW | Instrument, Biopsy | 1 |
| LDZ | Fixative, Alcohol Containing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 1998 | K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT Mill-Rose Laboratory | EOQ |
| Oct 30, 1998 | K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT Mill-Rose Laboratory | EOQ |
| May 23, 1997 | K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE Mill-Rose Laboratory | FDI |
| Jul 29, 1996 | K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE Mill-Rose Laboratory | EOQ |
| Apr 29, 1996 | K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH Mill-Rose Laboratory | EOQ |
| Dec 22, 1995 | K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE Mill-Rose Laboratory | FBK |
| Dec 18, 1995 | K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE Mill-Rose Laboratory | FDI |
| Nov 27, 1995 | K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES Mill-Rose Laboratory | FEB |
| Mar 24, 1995 | K951051 | RITE-BITE BIOPSY FORCEPS Mill-Rose Laboratory | EOQ |
| Mar 15, 1995 | K951048 | RITE-BITE BIOPSY FORCEPS Mill-Rose Laboratory | FCL |
| Feb 16, 1995 | K950559 | DIENER RETRIEVAL DEVICES Mill-Rose Laboratory | FCL |
| Feb 16, 1995 | K946293 | MILL-ROSE SCOPE CLEANING BRUSH Mill-Rose Laboratory | MNL |
| Nov 30, 1994 | K944649 | MILL-ROSE HARRELL BRONCHIAL BRUSH Mill-Rose Laboratory | EOQ |
| Nov 22, 1994 | K944650 | WANG BRONCHIAL NEEDLE BRUSH Mill-Rose Laboratory | EOQ |
| Jul 12, 1994 | K942630 | WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE Mill-Rose Laboratory | KNW |
| May 6, 1994 | K921680 | E-Z PEG Mill-Rose Laboratory | KNT |
| May 4, 1994 | K940521 | MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER Mill-Rose Laboratory | EOQ |
| Feb 22, 1994 | K935858 | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT Mill-Rose Laboratory | LRO |
| Jul 13, 1993 | K922204 | MILL-ROSE PULMONARY FORCEPS Mill-Rose Laboratory | EOQ |
| Feb 8, 1993 | K921800 | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 Mill-Rose Laboratory | FBK |
| Dec 10, 1991 | K914181 | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE Mill-Rose Laboratory | EOQ |
| Sep 24, 1991 | K910536 | PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER Mill-Rose Laboratory | EOQ |
| Jul 10, 1990 | K901995 | PLEURA BIOPSY DEVICE Mill-Rose Laboratory | GDM |
| Feb 9, 1990 | K895420 | SUCTION BIOPSY INSTRUMENT Mill-Rose Laboratory | FCK |
| Jul 24, 1989 | K894326 | THORACENTISIS KIT Mill-Rose Laboratory | GAA |
| Mar 17, 1989 | K884857 | COLONOSCOPE GUIDING TUBE DEVICE Mill-Rose Laboratory | FDF |
| Aug 1, 1986 | K862725 | SACCOMANNO SPECIMAN SOLUTION Mill-Rose Laboratory | LDZ |
| Apr 22, 1985 | K850489 | ENDOSOPIC STENE MANIPULATING BALLOON Mill-Rose Laboratory | LQR |
| Oct 2, 1984 | K842679 | ESOPHAGEAL DILATOR SET Mill-Rose Laboratory | FAT |
| Oct 31, 1983 | K833268 | ENDOSCOPIC OVERTUBE Mill-Rose Laboratory | FED |
| May 3, 1982 | K820771 | MICROBIOLOGY SPECIMEN BRUSH Mill-Rose Laboratory | BTG |
| Apr 29, 1982 | K820971 | DIATHERMIC HANDLE FOR BIOPSY FORCEPS Mill-Rose Laboratory | GEI |
| Apr 26, 1982 | K820983 | HOT BIOPSY FORCEPS W/ROUND CUPS Mill-Rose Laboratory | GEI |
| Apr 26, 1982 | K820980 | BIOPSY FORCEPS W/OVAL CUP & NEEDLE Mill-Rose Laboratory | GEN |
| Apr 26, 1982 | K820972 | BIOPSY FORCEPS W/OVAL CUPS Mill-Rose Laboratory | GEN |
| Apr 26, 1982 | K820970 | RETRIEVAL FORCEPS W/RATTOOTHED JAWS Mill-Rose Laboratory | GEN |
| Apr 26, 1982 | K820969 | BIOPSY FORCEPW W/SMALL OVAL CUPS Mill-Rose Laboratory | GEN |
| Apr 26, 1982 | K820968 | RETRIEVAL FORCEPS W/ALLIGATOR JAWS Mill-Rose Laboratory | GEN |
| Apr 26, 1982 | K820967 | BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS Mill-Rose Laboratory | GEN |
| Apr 16, 1982 | K820973 | ENDOSCOPIC INJECTION NEEDLE Mill-Rose Laboratory | FBK |
| Oct 23, 1980 | K802444 | PAPILLOTOME PRODUCT Mill-Rose Laboratory | KNS |
| Oct 23, 1980 | K802443 | E.R.C.P. CANNULA PRODUCT Mill-Rose Laboratory | ODD |
| Dec 20, 1979 | K792345 | RETRIEVABLE FORCEPS Mill-Rose Laboratory | OCZ |
| Dec 20, 1979 | K792344 | STONE AND RETRIEVAL BASKET Mill-Rose Laboratory | FFL |
| Dec 18, 1979 | K792343 | DIATHERMIC SNARE (CRESENT TYPE) Mill-Rose Laboratory | GEI |
| Oct 1, 1979 | K791668 | ENDOSCOPIC CYTOLOGY BRUSHES Mill-Rose Laboratory | FDX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||