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
159793–159816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1982
CORONARY INFUSION KIT
K822640 · DQO
Mallinckrodt Critical Care
Cardiovascular · 27d
Cleared Sep 28, 1982
TDX QUINIDINE
K822653 · LBZ
Abbott Laboratories
Toxicology · 26d
Cleared Sep 28, 1982
EMIT-AMD AMIKACIN ASSAY
K822657 · KLQ
Dade Behring, Inc.
Chemistry · 25d
Cleared Sep 28, 1982
CONCLUDE COMPOSITE LUTING CEMENT
K822714 · EBD
3M Company
Dental · 21d
Cleared Sep 28, 1982
ERIE OXYGEN CONCENTRATOR
K822719
Erie Controls
Cardiovascular · 21d
Cleared Sep 28, 1982
RESCUER
K822727 · CAE
Armstrong Ind., Inc.
Anesthesiology · 20d
Cleared Sep 28, 1982
K30000 DENTAL CHAIR
K822740 · KLC
Kaycor Intl., Ltd.
Dental · 19d
Cleared Sep 28, 1982
U.V.A.C. CURETTES
K822756 · HHD
American Hospital Supply Corp.
Obstetrics & Gynecology · 19d
Cleared Sep 28, 1982
ARTERIAL LINE KIT
K822760 · FMF
Martell Medical Products, Inc.
General Hospital · 14d
Cleared Sep 24, 1982
THREE SECOND THERMOMETER #TS-1000
K820948 · FLL
Temp-Stik Corp.
General Hospital · 171d
Cleared Sep 24, 1982
BE#6006 VAR. RESIS. INSPIR. MUSCLE
K821492 · BWF
Instrumentation Industries, Inc.
Anesthesiology · 129d
Cleared Sep 24, 1982
RETRIEVAL BALLOONS
K821818 · KOD
American Endoscopy, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 24, 1982
CADWELL 7400
K822214 · GWF
Cadwell Laboratories, Inc.
Neurology · 60d
Cleared Sep 24, 1982
THERMOTHERAPY
K822217 · LKX
Luther Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 24, 1982
ADHESIVE SPRAY #4050-4060
K822307 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 24, 1982
THE 3500
K822396 · GWF
Tracor Northern, Inc.
Neurology · 45d
Cleared Sep 24, 1982
VASOGRAPH, MODEL MV-2
K822455 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 39d
Cleared Sep 24, 1982
DISPOSABLE THERMOMETERS
K822502 · FLK
Hudson Oxygen Therapy Sales Co.
General Hospital · 32d
Cleared Sep 24, 1982
NEUROMEDICS ORIONS #660-01
K822600 · GZJ
Intermedics, Inc.
Neurology · 28d
Cleared Sep 24, 1982
LINEGUARD CATHETER SHIELD MODEL 100
K822732 · KMK
Ray-Marshall Laboratory
General Hospital · 16d
Cleared Sep 24, 1982
TRIEX-IH DIALYZER
K822738 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 15d
Cleared Sep 24, 1982
SOLID STATE CONTINUOUS FLOW CONTROL
K822743 · LJH
Widran Urological Group, Ltd.
Gastroenterology & Urology · 14d
Cleared Sep 22, 1982
MYO-TONE, INC. SYSTEM-80
K822250 · IPF
Myo-Tone, Inc.
Physical Medicine · 57d
Cleared Sep 22, 1982
DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB
K822354 · FPA
Valleylab, Inc.
General Hospital · 47d