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
163561–163584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1981
CASH ORTHOSIS
K812099 · IPY
David Hendricks, C.P.O.
Physical Medicine · 20d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY APPARATUS
K812103 · FFX
Honeywell, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 13, 1981
GILCHEM CREATININE REAGENT
K812109 · CGX
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
GILCHEM CALCIUM REAGENT
K812110 · CIC
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
MARRIA-HPRL RIA KIT
K812112 · CFT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 17d
Cleared Aug 13, 1981
COAT-A-COUNT DIGITOXIN RIA KIT
K812129 · DPG
Diagnostic Products Corp.
Toxicology · 17d
Cleared Aug 13, 1981
AMERLEX TSH RIA KIT
K812136 · JLW
Amersham Corp.
Chemistry · 16d
Cleared Aug 13, 1981
LIC 180 MEDICAL LAMPS
K812142 · KZF
Lada Intl., Inc.
General Hospital · 16d
Cleared Aug 13, 1981
LIFE-TECH #'S 1106/1156 UROLABS
K812178 · FAP
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 10d
Cleared Aug 12, 1981
USCI DOPPLER CATHETER SYSTEM
K810414 · JOP
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246 · DPW
Irex Corp.
Cardiovascular · 99d
Cleared Aug 12, 1981
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261 · DBL
Zeus Scientific, Inc.
Microbiology · 98d
Cleared Aug 12, 1981
MOORE HIP PROSTHESIS, PMMA COATED
K811416 · KWL
Zimmer, Inc.
Orthopedic · 85d
Cleared Aug 12, 1981
SP-100-B SMALL PARTS SCANNER SYSTEM
K811595 · DXK
Highstoy
Radiology · 65d
Cleared Aug 12, 1981
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · DDG
Kent Laboratories, Inc.
Immunology · 65d
Cleared Aug 12, 1981
BLUING REAGENT
K811800 · PPM
Richard-Allan Medical Ind., Inc.
Hematology · 49d
Cleared Aug 12, 1981
SICKLE CELL REAGENT SET
K811828 · GHM
Anco Medical Reagents & Assoc.
Chemistry · 44d
Cleared Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872 · DXZ
Ethicon, Inc.
Cardiovascular · 42d
Cleared Aug 12, 1981
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · GKL
Technicon Instruments Corp.
Hematology · 30d
Cleared Aug 12, 1981
SIMVAC
K811991 · CBO
The Lynn Terrell Co.
Anesthesiology · 30d
Cleared Aug 12, 1981
LPC II
K812031 · GKL
Labtronix Corp.
Hematology · 23d
Cleared Aug 12, 1981
ENDAB DIGOXIN KIT
K812054 · KXT
Immunotech Corp.
Toxicology · 22d
Cleared Aug 12, 1981
SPECTRO FEIRITIN
K812056 · DBF
Ramco Laboratories, Inc.
Microbiology · 22d
Cleared Aug 12, 1981
INSPIRATORY FORCE PRESSURE ADAPTOR
K812067 · BZA
Airlife, Inc.
Anesthesiology · 22d