FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
3529–3552 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 12, 2014
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium...
K142620 · NGT
Excelsior Medical Corporation
General Hospital · 87d
Cleared Dec 12, 2014
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141304 · LZA
Yongxin Healthcare Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141303 · LZA
Zhida Glove Co., Ltd.
General Hospital · 207d
Cleared Dec 11, 2014
Bi-Portal Bone Graft Delivery Device
K142661 · FMF
Spinal Surgical Strategies, LLC
General Hospital · 84d
Cleared Dec 11, 2014
SAPPHIRE INFUSION PUMP
K141389 · FRN
Q Core Medical , Ltd.
General Hospital · 198d
Cleared Dec 10, 2014
12 mm Endoscopes and Accessories
K142683 · NAY
Intuitive Surgical, Inc.
General Hospital · 82d
Cleared Dec 10, 2014
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
K142343 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 111d
Cleared Dec 08, 2014
Hospira Extension Set
K142433 · FPA
Hospira, Inc.
General Hospital · 101d
Cleared Dec 05, 2014
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · FPA
B.Braun Medical, Inc.
General Hospital · 247d
Cleared Dec 04, 2014
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
K141613 · LYZ
Zibo Goldenline Plastic Product Co.,...
General Hospital · 171d
Cleared Dec 04, 2014
CUROS RED PORT PROTECTOR
K140657 · QBP
Ivera Medical, Inc.
General Hospital · 265d
Cleared Dec 04, 2014
B TRAVELSAVVY SHARPS CONTAINER
K140285 · MMK
Bellegrove Medical Supply, Inc.
General Hospital · 303d
Cleared Dec 03, 2014
STERILUCENT SELF-SEAL STERILIZATION POUCH
K141412 · FRG
Gs Medical Packaging, Inc.
General Hospital · 188d
Cleared Dec 03, 2014
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
K141287 · LZA
Huikang Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141279 · LZA
Wanghui Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
K140589 · FRC
Mesa Laboratories, Inc.
General Hospital · 271d
Cleared Nov 26, 2014
Surgisleeve Wound Protector
K143091 · GCJ
Covidien, LLC
General Hospital · 29d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367 · FPA
Hospira, Inc.
General Hospital · 92d
Cleared Nov 25, 2014
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200...
K142270 · LYY
Hartalega Sdb. Bhd.
General Hospital · 102d
Cleared Nov 24, 2014
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
K140566 · JOJ
Crosstex International
General Hospital · 264d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234 · FPA
Care Fusion
General Hospital · 10d
Cleared Nov 19, 2014
VIAL-MATE Adaptor
K142600 · LHI
Baxter Healthcare Corporation
General Hospital · 65d
Cleared Nov 19, 2014
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
K142399 · QBP
Catheter Connections, Inc.
General Hospital · 84d