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
161041–161064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1982
PHENOBARBITAL FLUORESCENT IMMUNO
K821408 · LET
American Diagnostic Corp.
Toxicology · 13d
Cleared May 24, 1982
CORPAK-ENTERAL FEEDING CONTAINER
K821409 · KNT
Corpak Co.
Gastroenterology & Urology · 10d
Cleared May 24, 1982
CORPAK-MONITOR ENTERAL FEEDING CONTAIN
K821410 · KNT
Corpak Co.
Gastroenterology & Urology · 10d
Cleared May 21, 1982
KEYMED KEY VAC SUCTION PUMP
K820739 · BTA
Keymed, Inc.
General & Plastic Surgery · 64d
Cleared May 21, 1982
LESSER METATARSAL PHALANG. JOINT PROSTH
K820813 · KWH
Sutter Biomedical, Inc.
Orthopedic · 59d
Cleared May 21, 1982
GORE-TEX PERITONEAL CATHETERR
K820909 · FJS
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 50d
Cleared May 21, 1982
THORACIC DRAINAGE SYSTEM
K821023 · GCX
Howmedica Corp.
General Hospital · 38d
Cleared May 21, 1982
STERILE PATIENT EXAM. GLOVES
K821043 · FMC
Phoenix Glove Co.
General Hospital · 37d
Cleared May 21, 1982
DISPOSABLE THUMB FORCEPS
K821143 · GEN
Medcare Products
General & Plastic Surgery · 30d
Cleared May 21, 1982
BITE STICK
K821177 · FMA
Abco Dealers, Inc.
General Hospital · 24d
Cleared May 21, 1982
TRACELON
K821180 · BTR
Terumo Medical Corp.
Anesthesiology · 24d
Cleared May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214 · KNK
Omega Medical Electronics
Chemistry · 24d
Cleared May 21, 1982
ALBUMIN REAGENT
K821225 · CIX
Hi Chem, Inc.
Chemistry · 24d
Cleared May 21, 1982
RIAGEN B-HCG RIA
K821234 · JHI
Biogenex Laboratories
Chemistry · 23d
Cleared May 21, 1982
NEUROMATIC 2000
K821237 · IKN
Disa Electronics
Neurology · 23d
Cleared May 21, 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · CGS
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · JJY
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
ENDOTRACHEAL TUBE
K821243 · BTR
Life-Line Products, Inc.
Anesthesiology · 22d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247 · CGA
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 21, 1982
ESPREE' GUEDEL ESPREE BERMAN AIRWAY
K821308 · CAE
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
ESPREE', BREATHING BAG
K821309 · BTC
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
ESPREE' BREATHING CIRCUIT (W/ACCESS
K821311 · CAI
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
SERO/TEX RF TEST
K821319 · DHR
Texas Immunology, Inc.
Immunology · 17d
Cleared May 21, 1982
TRANSENDOSCOPIC INJECTION CATHETER TEI
K821336 · KNY
Sounson Research Co., Inc.
Gastroenterology & Urology · 16d