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
164161–164184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1981
AXICARE BREAST PUMP MODEL
K811403 · HGX
Neonatal Corp.
Obstetrics & Gynecology · 25d
Cleared Jun 12, 1981
STERILIZATION INDICATOR/SEAL PROTECTOR
K811408 · JOJ
Beacon Converters, Inc.
General Hospital · 24d
Cleared Jun 12, 1981
MEDI-TRACE
K811410 · KRA
Graphic Controls Corp.
Cardiovascular · 24d
Cleared Jun 12, 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · KRB
American Edwards Laboratories
Cardiovascular · 24d
Cleared Jun 12, 1981
BAIM CORONARY SINUS FLOW ANALYZER
K811414 · DXG
Electro-Catheter Corp.
Cardiovascular · 24d
Cleared Jun 12, 1981
SPRIO-LOOP
K811419 · BTX
Datamed, Inc.
General & Plastic Surgery · 24d
Cleared Jun 12, 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
EXP 600 PARALLEL PLATE DIALYZER
K811440 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
HYDRON WOUND DRESSING KIT
K811446 · KMF
National Patent Development Corp.
General & Plastic Surgery · 21d
Cleared Jun 12, 1981
ORTHO-FRAC KIT
K811456 · IQI
Orthomedics
Physical Medicine · 21d
Cleared Jun 12, 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463 · FPA
Baxter Healthcare Corp
General Hospital · 17d
Cleared Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
MMG URINARY DRAINAGE TUBING
K811469 · KNX
Medical Marketing Group
Gastroenterology & Urology · 17d
Cleared Jun 12, 1981
LIFESPAN 100
K811470 · KLK
Biochem International, Inc.
Anesthesiology · 17d
Cleared Jun 12, 1981
BOOK HOLDER
K811487 · ILP
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
FEEDING AID KIT
K811488 · ILC
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
SCOOTER BOARD
K811489 · KNL
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
FOREARM & KNEE STRAPS
K811490 · IQI
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
WHEELCHAIR ACCESSORIES
K811491 · KNO
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
DRESSING ADAPTORS
K811492 · ILD
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
CRUTCH & WALKER PADS
K811493 · INP
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
MODELS TA 1017 & 1017T GRITIFLO DISPOS
K811538 · DRS
Gould, Inc.
Cardiovascular · 11d