Company
Mckesson Medical-Surgical Inc. Corporate Office
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
119recalls (0 in 12 months)
59recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRO | Dressing, Wound, Drug | 8 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| JIT | Calibrator, Secondary | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 |
| JSM | Culture Media, Non-Propagating Transport | 3 |
| LRJ | Disinfectant, Medical Devices | 3 |
| FMF | Syringe, Piston | 2 |
| FRC | Indicator, Biological Sterilization Process | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| GER | 2 | |
| GTY | Antigens, All Groups, Streptococcus Spp. | 2 |
| JGY | Colorimetric Method, Triglycerides | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| KXG | Applicator, Absorbent Tipped, Sterile | 2 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 2 |
| MED | Sterilant, Medical Devices | 2 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2025 | Mckesson Medical-Surgical Inc. Corporate Office Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 Open, Classified |
GTY | K010582 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. Open, Classified |
JJX | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. Open, Classified |
JJX | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. Open, Classified |
NHX | K083868 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. Open, Classified |
MTG | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. Open, Classified |
LOM | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. Open, Classified |
CGL | K053110 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. Open, Classified |
MZF | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. Open, Classified |
JZO | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. Open, Classified |
JZO | K052407 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. Open, Classified |
LOM | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. Open, Classified |
JJE | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. Open, Classified |
JIX | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. Open, Classified |
JJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. Open, Classified |
JJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. Open, Classified |
CDN | K001885 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. Open, Classified |
QHR | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT. Open, Classified |
CJE | K190807 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. Open, Classified |
PPM | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. Open, Classified |
LEH | K043386 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. Open, Classified |
CEO | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. Open, Classified |
CJY | K072440 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. Open, Classified |
LCP | K171650 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA. Open, Classified |
JSI | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA. Open, Classified |
JSG | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. Open, Classified |
CGA | K911141 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST. Open, Classified |
JGY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES. Open, Classified |
JGY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL Open, Classified |
JJY | None listed |
| Oct 22, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2
6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test Open, Classified |
JJW | K874890 |
| Jun 7, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body
MMS Catalog Number: 1159851
Cardinal Catalog Number: 8881560125 Completed |
FMF | K131641 |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 3 1.7 mL Open, Classified |
JJY | K972868 |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL Open, Classified |
JJY | K972868 |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Open, Classified |
MNL | None listed |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL Open, Classified |
JJX | K050328 |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis Open, Classified |
MXB | K050755 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313.
b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 24PK/CS) Catalog # 1322.
c. DYNAREX dynacare WIPE, WE Open, Classified |
LRJ | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145 Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158 Open, Classified |
FRO | K162508 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.7 Open, Classified |
FRO | K090453 K183645 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) C Open, Classified |
FRO | K090453 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453.
b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454 Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS Open, Classified |
FRO | K101793 K921290 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140 Open, Classified |
GAQ | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Skin markers:
a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005.
b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20. Open, Classified |
IYE | K014022 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042.
b. Open, Classified |
GER | K080497 K921290 |
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