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

Filters: Cleared only ×
176,076 results
75913–75936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · JIT
Dade Behring, Inc.
Immunology · 87d
Cleared Jun 21, 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · GAL
Gramsmed, LLC
General & Plastic Surgery · 81d
Cleared Jun 21, 2002
CINESCAN S
K021683 · IYO
Quantel Medical
Radiology · 30d
Cleared Jun 21, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45...
K021701 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 29d
Cleared Jun 21, 2002
HORIZONS HOT BIOPSY FORCEPS
K021706 · KGE
Horizons Intl. Corp.
Gastroenterology & Urology · 29d
Cleared Jun 21, 2002
RT-PLUS PE INSERT CLAMP
K021714 · KRO
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 21, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K021729 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 21, 2002
VISUCAM
K021787 · NFF
Carl Zeiss Ophthalmic Systems, Inc.
Ophthalmic · 22d
Cleared Jun 20, 2002
EQUATION FIXATION SYSTEM
K013962 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 199d
Cleared Jun 20, 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279 · MNI
Forex Corp.
Orthopedic · 143d
Cleared Jun 20, 2002
TIPOWER POWERDRIVE AND RIMPOWER X & SX
K020539 · ITI
Tisport
Physical Medicine · 121d
Cleared Jun 20, 2002
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
K020639 · ITI
Tisport
Physical Medicine · 113d
Cleared Jun 20, 2002
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
K020967 · CBZ
Terumo Cardiovascular Systems Corp.
Anesthesiology · 87d
Cleared Jun 20, 2002
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6...
K020999 · NGT
Medefil, Inc.
General Hospital · 84d
Cleared Jun 20, 2002
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
K021008 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 84d
Cleared Jun 20, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184 · LTT
Dade Microscan, Inc.
Microbiology · 66d
Cleared Jun 20, 2002
NIVEOUS LIQUID DAM
K021613 · EIE
Shofu Dental Corp.
Dental · 35d
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jun 20, 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · DQY
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jun 19, 2002
SLEEP PAT 200 DEVICE
K010156 · MNR
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 519d
Cleared Jun 19, 2002
OXYGEN TREATMENT HOOD
K011592 · CBF
Amron International Diving Supply, Inc.
Anesthesiology · 391d
Cleared Jun 19, 2002
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
K013896 · MKJ
Defibtech, LLC
Cardiovascular · 208d
Cleared Jun 19, 2002
DEVILBISS PD1000
K020329 · NFB
Sunrise Medical Hhg, Inc.
Anesthesiology · 139d