FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128401–128424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1989
AMBULATORY INFUSION PUMP
K895426 · FRN
Bionica, Inc.
General Hospital · 113d
Cleared Dec 27, 1989
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · JIH
Baxter Healthcare Corp
Chemistry · 107d
Cleared Dec 27, 1989
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · GBX
Arrow Intl., Inc.
General & Plastic Surgery · 106d
Cleared Dec 27, 1989
LIFEPORT VASCULAR ACCESS PORT
K895689 · LJT
Strato Medical Corp.
General Hospital · 96d
Cleared Dec 27, 1989
MIKRO-LAVAGE-1
K895755 · GBX
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Dec 27, 1989
MIKRO-AQUAPURATOR
K895756 · GBX
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Dec 27, 1989
NON CONSTRAINED TOTAL SHOULDER SYSTEM
K895802 · KWT
Orthopaedic Medical Group, Inc.
Orthopedic · 90d
Cleared Dec 27, 1989
SERENE WRAP
K895865 · EFQ
Byron Medical
General & Plastic Surgery · 86d
Cleared Dec 27, 1989
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883 · JIQ
Beckman Instruments, Inc.
Chemistry · 83d
Cleared Dec 27, 1989
BANDAGE REMOVAL STRIP
K895884 · KGX
Kut-Guard, Inc.
General & Plastic Surgery · 83d
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943 · JJY
Sclavo, Inc.
Chemistry · 77d
Cleared Dec 27, 1989
LATEX EXAMINATION GLOVES
K896003 · LYY
Jiea Chao Ent. Co., Ltd.
General Hospital · 75d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
MODEL 6500 MERCURY ARC LIGHT SOURCE
K896008 · GCP
Medical Dynamics, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
K896111 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Dec 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 65d
Cleared Dec 27, 1989
SUNTANNING BED, INC. T12 UVA TANNING LAMPS
K896191 · FTC
Sunbronze
General & Plastic Surgery · 62d
Cleared Dec 27, 1989
WILSON-COOK ESOPHAGEAL PROSTHESIS
K896390 · JCQ
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 51d
Cleared Dec 27, 1989
ARTHROSCOPIC TUBING SHEATH
K896584 · HRX
Origin Medsystems, Inc.
Orthopedic · 36d
Cleared Dec 27, 1989
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
K896589 · LRZ
Optik
General & Plastic Surgery · 36d
Cleared Dec 27, 1989
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 36d
Cleared Dec 27, 1989
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641 · CFT
Medix Biotech, Inc.
Chemistry · 33d
Cleared Dec 27, 1989
STREAMLINE VASCULAR ACCESS DEVICE
K896774 · FOZ
Menlo Care, Inc.
General Hospital · 26d
Cleared Dec 27, 1989
SURGICAL SKIN MARKER
K896792 · FZZ
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d