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
55585–55608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2008
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · CAF
Health & Life Co., Ltd.
Anesthesiology · 90d
Cleared Sep 17, 2008
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
K081742 · ETN
Baxano, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 17, 2008
MASTERGRAFT PUTTY
K081784 · LYC
Medtronic Sofamor Danek
Dental · 85d
Cleared Sep 17, 2008
SPY ANALYSIS TOOLKIT, MODEL SA9000
K081792 · LLZ
Novadaq Technologies, Inc.
Radiology · 84d
Cleared Sep 17, 2008
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · EBG
Pulpdent Corporation
Dental · 83d
Cleared Sep 17, 2008
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Sep 17, 2008
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · JJY
Cliniqa Corporation
Chemistry · 54d
Cleared Sep 17, 2008
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121 · CGA
Eps Bio Technology Corp.
Chemistry · 51d
Cleared Sep 17, 2008
INFRARED EAR THERMOMETER, MODEL ET-101A
K082192 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 44d
Cleared Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
K082362 · FOZ
Terumo Medical Corp.
General Hospital · 30d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · HWC
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Sep 17, 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 14d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · LCP
Tosoh Bioscience, Inc.
Chemistry · 512d
Cleared Sep 16, 2008
SILVERMED ANTIMICROBIAL SILVER HYDROGEL
K073019 · FRO
Argentis Biomedical Incorporated
General & Plastic Surgery · 327d
Cleared Sep 16, 2008
MODIFICATION TO AURORA MRI SYSTEM
K073425 · LNH
Aurora Imaging Technology, Inc.
Radiology · 288d
Cleared Sep 16, 2008
G-1 V5
K081114 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 151d
Cleared Sep 16, 2008
G-2 V5
K081117 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 151d
Cleared Sep 16, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K082023 · NLH
Ascent Healthcare Solutions
Cardiovascular · 62d
Cleared Sep 16, 2008
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM
K082270 · MAX
Vertiflex, Inc.
Orthopedic · 36d
Cleared Sep 16, 2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · OCL
St Jude Medical
Cardiovascular · 36d
Cleared Sep 16, 2008
INREACH PLANNING LAPTOP
K082386 · LLZ
Superdimension, Ltd.
Radiology · 28d
Cleared Sep 15, 2008
SUPRAMESH EXTRA
K080216 · FTL
S. Jackson, Inc.
General & Plastic Surgery · 230d
Cleared Sep 15, 2008
PTFE INTERLOCK PEELABLE INTRODUCERS
K081394 · DYB
Enpath Medical, Inc.
Cardiovascular · 119d
Cleared Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · NKB
Blackstone Medical, Inc.
Orthopedic · 90d