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
62617–62640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2006
IKOENGELO
K061006 · KPQ
Ikoetech, LLC
Radiology · 55d
Cleared Jun 05, 2006
TIGERVIEW PROFESSIONAL
K061035 · LLZ
Televere Systems
Radiology · 52d
Cleared Jun 05, 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
K061235 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 33d
Cleared Jun 05, 2006
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND...
K061308 · FYA
Cardinal Health 200, Inc.
General Hospital · 26d
Cleared Jun 05, 2006
ORAL-B SONIC COMPLETE
K061351 · JEQ
Braun GmbH
Dental · 21d
Cleared Jun 05, 2006
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K061426 · CAH
Porous Media Corp.
General Hospital · 13d
Cleared Jun 02, 2006
MEDICAL INTERPOROUS
K051342 · EFT
Bonyf AG
Dental · 375d
Cleared Jun 02, 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
K053305 · LYY
Pt Mahakarya Inti Buana
General Hospital · 186d
Cleared Jun 02, 2006
RITRACT SAFETY SYRINGE
K060002 · MEG
Ritract , Ltd.
General Hospital · 150d
Cleared Jun 02, 2006
STOCKERT S5 SYSTEM
K060053 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 147d
Cleared Jun 02, 2006
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138 · MQN
Synthes (Usa)
Dental · 134d
Cleared Jun 02, 2006
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · KWD
Osteomed LP
Orthopedic · 94d
Cleared Jun 02, 2006
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K060563 · CAZ
Pajunk GmbH
Anesthesiology · 114d
Cleared Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
K060641 · NOM
Bio-Rad
Microbiology · 84d
Cleared Jun 02, 2006
ACCIN UNI-KNEE SYSTEM
K060670 · HSX
Accin Corporation
Orthopedic · 80d
Cleared Jun 02, 2006
LARIAT LOOP APPLICATOR
K060721 · GAT
Sentreheart
General & Plastic Surgery · 77d
Cleared Jun 02, 2006
MBCP GEL
K060732 · LYC
Biomatlante
Dental · 74d
Cleared Jun 02, 2006
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
K060744 · LRK
O'Brien Dental Lab, Inc.
Dental · 74d
Cleared Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH...
K061031 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 49d
Cleared Jun 02, 2006
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM,...
K061073 · DXN
Taidoc Technology Corporation
Chemistry · 46d
Cleared Jun 02, 2006
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX...
K061079 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 46d
Cleared Jun 02, 2006
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
K061171 · DQX
Biosphere Medical, Inc.
Cardiovascular · 36d
Cleared Jun 02, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
K061240 · LJS
Lucent Medical Systems
General Hospital · 30d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Abbott Laboratories
Toxicology · 29d