FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75313–75336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 19, 2002
WORKBENCH BY
K020560 · MQG
Intl., Inc.
Obstetrics & Gynecology · 119d
Cleared Jun 19, 2002
PALOMAR LUXG HANDPIECE
K020941 · GEX
Palomar
General & Plastic Surgery · 89d
Cleared Jun 19, 2002
GLO-SPEC I, II AND III
K020959 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 86d
Cleared Jun 19, 2002
LEESPEC DISPOSABLE VAGINAL SPECULUM
K021017 · HIB
Itl Corporation Pty, Ltd.
Obstetrics & Gynecology · 82d
Cleared Jun 19, 2002
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
K021089 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 76d
Cleared Jun 19, 2002
ELEMENTS DIAGNOSTIC UNIT
K021298 · EAT
Sybron Endo/Analytic
Dental · 56d
Cleared Jun 19, 2002
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K021567 · CAZ
Arrow Intl., Inc.
Anesthesiology · 37d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 30d