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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50449–50472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2010
THE MOSES APPLIANCE
K093710 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 161d
Cleared May 12, 2010
TRILOGY 202 VENTILATOR
K093905 · CBK
Respironics, Inc.
Anesthesiology · 141d
Cleared May 12, 2010
CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
K094012 · CCK
Oridion Capnography, Inc.
Anesthesiology · 134d
Cleared May 12, 2010
FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE
K100235 · EBF
3M Company
Dental · 106d
Cleared May 12, 2010
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
K100336 · OQO
Eragen Biosciences
Microbiology · 96d
Cleared May 12, 2010
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503 · LBH
Pulpdent Corporation
Dental · 79d
Cleared May 12, 2010
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL...
K100537 · NLQ
Ascent Healthcare Solutions
General & Plastic Surgery · 76d
Cleared May 12, 2010
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
K100560 · NBW
Biotest Medical Corp.
Chemistry · 72d
Cleared May 12, 2010
GLIDER PTA BALLOON CATHETER
K101062 · LIT
Trireme Medical, Inc.
Cardiovascular · 26d
Cleared May 12, 2010
NUANCE
K101215 · EBF
Discus Dental, LLC
Dental · 12d
Cleared May 11, 2010
ACE STAPLER, MODEL F0031
K082044 · OCW
Barosense, Inc.
Gastroenterology & Urology · 662d
Cleared May 11, 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED...
K092190 · KTT
Synthes (Usa)
Orthopedic · 294d
Cleared May 11, 2010
ZIT-Z
K092507 · DZE
Ziterion
Dental · 267d
Cleared May 11, 2010
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812 · HRS
Synthes (Usa)
Orthopedic · 239d
Cleared May 11, 2010
VELA VENTILATOR
K093094 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 222d
Cleared May 11, 2010
INTELLIVUE PATIENT MONITOR
K093268 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 204d
Cleared May 11, 2010
AESCULAP STERILCONTAINER S
K093649 · FRG
Aesculap
General Hospital · 167d
Cleared May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · HRS
Exactech, Inc.
Orthopedic · 138d
Cleared May 11, 2010
ZZOMA POSITIONAL SLEEPER MODEL 001
K100160 · MYB
Sleep Specialists, LLC
Ear, Nose, Throat · 111d
Cleared May 11, 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH...
K100211 · LYY
Shen Wei (Usa), Inc.
General Hospital · 106d
Cleared May 11, 2010
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 104d
Cleared May 11, 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406 · CGA
Taidoc Technology Corporation
Chemistry · 84d
Cleared May 11, 2010
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
K100691 · IYE
Bionix Development Corp.
Radiology · 62d
Cleared May 11, 2010
BARIREP
K100839 · FRO
Gorbec Pharmaceutical Services, Inc.
General & Plastic Surgery · 48d