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

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176,076 results
81145–81168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2000
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
K002803 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 110d
Cleared Dec 27, 2000
PELVIC MUSCLE THERAPY
K002830 · HIR
Colonial Medical Supply
Gastroenterology & Urology · 107d
Cleared Dec 27, 2000
COMPUMEDICS SIESTA SYSTEM
K003175 · OLV
Compumedics Limited
Neurology · 78d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230 · JAK
Vital Images, Inc.
Radiology · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516 · LNH
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 27, 2000
XISCAN 6000 IMAGING SYSTEM
K003568 · OXO
Xitec, Inc.
Radiology · 37d
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643 · DQY
NuMED, Inc.
Cardiovascular · 30d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Dec 27, 2000
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · INI
Merits Health Products., Inc.
Physical Medicine · 16d
Cleared Dec 26, 2000
CRYOSURGICAL UNIT AND ACCESSORIES
K003050 · GEI
Cryogen, Inc.
General & Plastic Surgery · 85d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · DCN
Diagnostic Products Corp.
Immunology · 57d
Cleared Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
K003677 · GKZ
Abx Diagnostics
Hematology · 27d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 22, 2000
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
K001955 · GEI
Aaron Medical Industries
General & Plastic Surgery · 178d
Cleared Dec 22, 2000
BIOTEQ I.V. (INTRAVENOUS) SET
K002449 · FPA
Bioteque Corp.
General Hospital · 135d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER,...
K002976 · DRF
St Jude Medical
Cardiovascular · 88d
Cleared Dec 22, 2000
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL...
K003036 · KYG
Retinalabs.Com
Ophthalmic · 84d
Cleared Dec 22, 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · KGN
Adri/Technam
General & Plastic Surgery · 77d
Cleared Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · JIF
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Dec 22, 2000
EHC400 DESKTOP PATIENT STATION
K003257 · CGA
Cybercare Technologies, Inc.
Chemistry · 65d
Cleared Dec 22, 2000
CLEANAIR/ CLEANWATER UNIT, MODEL 1600
K003265 · EIA
Texas Institute For Conservative...
Dental · 65d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · JAQ
Nucletron Corp.
Radiology · 65d
Cleared Dec 22, 2000
PEDIATRIC INGESTASCAN
K003305 · HPM
Adams Electronics, Inc.
Ophthalmic · 63d