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
163129–163152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1981
KONTRON PMS 7000
K812354 · DQK
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Sep 25, 1981
ADAPTIC* C.F.S.
K812449 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 28d
Cleared Sep 25, 1981
EXMOOR AURAL GROMMET AG/TI
K812459 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 25d
Cleared Sep 25, 1981
2000 SERIES PORTABLE RESUSCITATION SYST.
K812519 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
280/4 MINI-DEFIBRILLATOR
K812520 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
BEAUFILL
K812545 · EBF
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
BEAUDENT
K812546 · EBF
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
COBEAU
K812548 · LBH
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
BEAUSEAL
K812549 · EBC
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
BEAUCAV
K812550 · LBH
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · DYG
American Edwards Laboratories
Cardiovascular · 17d
Cleared Sep 25, 1981
CAVITRON
K812568 · EMA
G-C Intl. Corp.
Dental · 16d
Cleared Sep 25, 1981
SHERWOOD WATER TRAP
K812569 · BYH
Sherwood Medical Co.
Anesthesiology · 16d
Cleared Sep 25, 1981
VELCRO FINGER/TOE SPLINT
K812654 · ILH
Maddak, Inc.
Physical Medicine · 8d
Cleared Sep 25, 1981
VELCRO SPLINT STRAP FASTENERS
K812655 · ILH
Maddak, Inc.
Physical Medicine · 8d
Cleared Sep 24, 1981
LACTIC ACID DIALYSATE ADDITIVE
K811706 · KPO
Edlaw Pharmaceuticals, Inc.
Chemistry · 100d
Cleared Sep 24, 1981
CELL-CHEX RBC
K811741 · KRX
Streck Laboratories, Inc.
Hematology · 97d
Cleared Sep 24, 1981
CAROTID ARTERY CLAMP & TOOLS
K811821 · HCE
New England Surgical Instrument Corp.
Neurology · 87d
Cleared Sep 24, 1981
TOWNLEY UNICONDYLAR KNEE
K812012 · HRY
Depuy, Inc.
Orthopedic · 69d
Cleared Sep 24, 1981
INFANT APNEA MONITOR MODEL 100
K812045 · BZQ
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 65d
Cleared Sep 24, 1981
LOW FIBRINOGEN CONTROL
K812108 · KQJ
Bio/Data Corp.
Hematology · 59d
Cleared Sep 24, 1981
LAPIN CLEAR CUT II
K812125 · GEI
Promed Corp.
General & Plastic Surgery · 59d
Cleared Sep 24, 1981
HEMODIALYSIS TRANSDUCER PROTECTOR
K812162 · FIB
Membrana
Gastroenterology & Urology · 57d
Cleared Sep 24, 1981
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
K812227 · CFP
Clinical Assays, Inc.
Chemistry · 45d