Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
166297–166320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1980
URETHRAL CATHETERIZATION TRAYS
K801785 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 21, 1980
URINARY CATHETER CARE TRAYS #3700&3710
K801787 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 21, 1980
FOLEY CATHETERIZATION TRAY
K801820 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 20, 1980
HEPA-SHURE -L
K802120 · JJK
Nuclear Medical Laboratories, Inc.
Hematology · 46d
Cleared Oct 20, 1980
EMIT-STM URINE CONTROLS
K802622
Syva Co.
Toxicology
Cleared Oct 17, 1980
REGIONAL INTRAVENOUS ANESTHESIA KIT
K802290 · CAZ
Stanco Medical, Inc.
Anesthesiology · 28d
Cleared Oct 13, 1980
FIGURETRIM
K802269 · IPF
Colne Medical Co. , Ltd.
Physical Medicine · 26d
Cleared Oct 10, 1980
BED ROCKING DEVICE
K801517 · FNJ
Wesler
General Hospital · 101d
Cleared Oct 10, 1980
SERO STREP KIT
K801775 · GTZ
Sacks Farms Biological Products
Microbiology · 74d
Cleared Oct 10, 1980
AUTOLET
K801815 · JCA
Ulster Scientific, Inc.
Hematology · 72d
Cleared Oct 10, 1980
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841 · GHH
American Hospital Supply Corp.
Hematology · 70d
Cleared Oct 10, 1980
S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX
K801860 · EJK
Pennwalt Corp.
Dental · 66d
Cleared Oct 10, 1980
INPERSOL-CAPD ADMINISTRATION SET
K801881 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 64d
Cleared Oct 10, 1980
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
K801884 · FPX
Acme United Corp.
General & Plastic Surgery · 64d
Cleared Oct 10, 1980
GLUCOSE DIAGNOSTIC REAGENT
K801897 · CGA
Connecticut Diagnostics, Ltd.
Chemistry · 63d
Cleared Oct 10, 1980
URIC ACID DIAGNOSTIC REAGENT
K801898 · KNK
Connecticut Diagnostics, Ltd.
Chemistry · 63d
Cleared Oct 10, 1980
ANTI-DS/N-DNA TEST KIT
K801960 · DBL
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 10, 1980
RF-II TEST KIT
K801961 · DHR
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 10, 1980
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI
K801964 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Oct 10, 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Oct 10, 1980
DRESSING CHANGE SET CAT.#910-930
K802017 · KDD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 51d
Cleared Oct 10, 1980
VIALON SURGEON'S GLOVES
K802027 · KGO
Rivefain Corp.
General Hospital · 50d
Cleared Oct 10, 1980
CO2 MICROSURGICAL LASER SYSTEM #370
K802034 · EWG
Metricon, Ltd.
Ear, Nose, Throat · 49d
Cleared Oct 10, 1980
STERILE TONSIL SPONGES
K802060 · GDY
Medspec Corp.
General & Plastic Surgery · 46d