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
48265–48288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2011
PSORIA-LIGHT
K103540 · FTC
Psoria-Shield, Inc.
General & Plastic Surgery · 70d
Cleared Feb 10, 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553 · JJX
Bionostics, Inc.
Chemistry · 69d
Cleared Feb 10, 2011
VENOFER PUMP
K103564 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 10, 2011
REUSABLE LINEAR STAPLER HANDLE
K110049 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 34d
Cleared Feb 10, 2011
SPPHINE PLUS STM 3W DIODE LASER
K110079 · GEX
Den-Mat Holdings, LLC
General & Plastic Surgery · 30d
Cleared Feb 09, 2011
PULSE OXIMETER MODEL P10
K100225 · DQA
Mediana Co., Ltd.
Anesthesiology · 379d
Cleared Feb 09, 2011
FUSE PLIF CAFE
K100945 · MAX
Advanced Medical Technologies AG
Orthopedic · 309d
Cleared Feb 09, 2011
EXPLORER LIVER (PASSIVE TRACKING)
K101979 · OEW
Pathfinder Therapeutics, Inc.
General & Plastic Surgery · 210d
Cleared Feb 09, 2011
VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP...
K102296 · JOJ
STERIS Corporation
General Hospital · 180d
Cleared Feb 09, 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · MNH
L & K Biomed Co., Ltd.
Orthopedic · 113d
Cleared Feb 09, 2011
HAMMERLOC TM TIBIAL FIXATION DEVICE
K103145 · MBI
Biomet Sports Medicine
Orthopedic · 107d
Cleared Feb 09, 2011
CRYONIZE TM
K103310 · GEH
3jt Enterprises, LLC
General & Plastic Surgery · 91d
Cleared Feb 09, 2011
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K110010 · GZL
Blackrock Microsystems, Inc.
Neurology · 37d
Cleared Feb 09, 2011
AAIO-7, AAIO WIRLESS
K110205 · HLI
Appasamy Associates
Ophthalmic · 15d
Cleared Feb 08, 2011
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM,...
K100533 · GCJ
Vibrynt, Inc.
General & Plastic Surgery · 348d
Cleared Feb 08, 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/...
K101236 · IYN
Ge Healthcare
Radiology · 281d
Cleared Feb 08, 2011
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · DZL
Jeil Medical Corporation
Dental · 215d
Cleared Feb 08, 2011
HEAL FORCE CO2 INCUBATOR
K101988 · MQG
Shanghai Lishen Scientific Equipment...
Obstetrics & Gynecology · 209d
Cleared Feb 08, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K103040 · NKB
Lanx, LLC
Orthopedic · 118d
Cleared Feb 08, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · MNI
Phygen, LLC
Orthopedic · 111d
Cleared Feb 08, 2011
TRILLIANT SURGICAL SUBTALAR IMPLANT
K103183 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 103d
Cleared Feb 08, 2011
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
K103186 · MKJ
Leonhard Lang GmbH
Cardiovascular · 102d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195 · CGA
Abbott Point of Care, Inc.
Chemistry · 102d
Cleared Feb 08, 2011
INTEL HEALTH GUIDE
K103276 · DRG
Intel Corporation Digital Health Group
Cardiovascular · 95d