Cypress Medical Products LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 26
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3185-2024 | Class II | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 | August 20, 2024 |
| Z-3184-2024 | Class II | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | August 20, 2024 |
| Z-3154-2024 | Class II | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson | August 6, 2024 |
| Z-2940-2024 | Class II | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL | July 24, 2024 |
| Z-2473-2021 | Class II | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121 | August 11, 2021 |
| Z-1080-2019 | Class III | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30 | February 27, 2019 |
| Z-0119-2019 | Class II | McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indicati | September 4, 2018 |
| Z-2828-2018 | Class II | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for us | July 2, 2018 |
| Z-0932-2018 | Class II | 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson | November 17, 2017 |
| Z-0741-2017 | Class II | McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 1 | October 12, 2016 |
| Z-1273-2013 | Class II | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by | April 15, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | July 12, 2002 |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | August 6, 2001 |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | July 7, 1998 |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | May 28, 1998 |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | February 26, 1998 |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | July 5, 1995 |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | March 31, 1995 |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | February 27, 1995 |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | February 27, 1995 |
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | December 8, 1994 |
| K921988 | LACERATION REPAIR TRAY | November 19, 1992 |
| K920480 | DRESSING CHANG & WOUND MANAGEMENT | October 19, 1992 |
| K914475 | IV START KIT | March 18, 1992 |
| K915430 | SKIN STAPLE REMOVER KIT | February 28, 1992 |
| K896129 | URINARY LEG BAG | April 16, 1990 |
| K897054 | CLINICAL MERCURY THERMOMETER | March 22, 1990 |
| K890728 | STERILE IRRIGATION TRAYS | June 16, 1989 |
| K890465 | CLOSED SYSTEM URINARY DRAINAGE BAG | May 23, 1989 |
| K891941 | PATIENT EXAMINATION GLOVES (VINYL) | May 8, 1989 |
| K892086 | PATIENT EXAMINATION GLOVES (LATEX) | May 4, 1989 |