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
162289–162312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1982
WOUND CLOSURE INSTRUMENT TRAY
K812133 · FSM
E.M. Adams
General & Plastic Surgery · 164d
Cleared Jan 08, 1982
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
K813335 · FSH
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 45d
Cleared Jan 07, 1982
EAST-FREEMAN VENTILATOR MARK 2
K812958 · CBK
Cairco , Ltd.
Anesthesiology · 78d
Cleared Jan 07, 1982
THE CHICAGO GULLET
K813132 · KNT
Universal Prosthetics, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 07, 1982
YOSHIDA RIDO-F, MODEL LM-01
K813348 · EKX
Kaycor Intl., Ltd.
Dental · 41d
Cleared Jan 07, 1982
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 41d
Cleared Jan 07, 1982
CAULK OPAQUER
K813357 · EBF
Dentsply Intl.
Dental · 41d
Cleared Jan 07, 1982
EYE CHARTS
K813376 · HOX
Abco Dealers, Inc.
Ophthalmic · 37d
Cleared Jan 07, 1982
DISPOSABLE NEONATAL VENTILATION CIRCUIT
K813384 · BZO
Intec.
Anesthesiology · 36d
Cleared Jan 07, 1982
INZOMA P
K813417 · EJT
J. Aderer, Inc.
Dental · 31d
Cleared Jan 07, 1982
INZOMA NP
K813418 · EJS
J. Aderer, Inc.
Dental · 31d
Cleared Jan 07, 1982
OXYCON
K813436 · CAW
Home Medical Mfg., Co., Inc.
Anesthesiology · 30d
Cleared Jan 07, 1982
POTTS-COURNAND STYLE NEEDLE
K813448 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 27d
Cleared Jan 07, 1982
CHIBA SKINNY NEEDLE
K813460 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 27d
Cleared Jan 07, 1982
DISPOSABLE TRANSDUCER
K813464 · DRS
Sorensen Research
Cardiovascular · 27d
Cleared Jan 07, 1982
4004 CONSTANT FLOW REGULATOR
K813466 · CAN
Safety Laboratories West
Anesthesiology · 27d
Cleared Jan 07, 1982
2002 ADJUSTABLE FLOW REGULATOR
K813467 · CAN
Safety Laboratories West
Anesthesiology · 27d
Cleared Jan 07, 1982
ACC-U-THERM TEMPERATURE MONITOR
K813468 · FLL
Diatek, Inc.
General Hospital · 27d
Cleared Jan 07, 1982
ARGYLE PEDIATRIC URINE COLLECTOR
K813479 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 37d
Cleared Jan 07, 1982
VERSION OF A CLOSED-FLOW SYS. CALORIC
K813490 · ETF
Thomas M. Foti, M.D.
Ear, Nose, Throat · 34d
Cleared Jan 07, 1982
MEDIFIX
K813498 · KRK
Burron Medical Products, Inc.
Cardiovascular · 24d
Cleared Jan 07, 1982
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
K813504 · KOA
Midwest Metabolic Support Group
Gastroenterology & Urology · 23d
Cleared Jan 05, 1982
TM-CAPD
K812615 · KPP
Tri-Med, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 05, 1982
RELAXATION TANK
K812724
Float-To-Relax, Inc.
Physical Medicine · 99d