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
48673–48696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2010
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
K101782 · MSS
Staar Japan
Ophthalmic · 180d
Cleared Dec 22, 2010
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K101861 · HKI
Truevision Systems, Incorporated
Ophthalmic · 173d
Cleared Dec 22, 2010
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
K102007 · CAZ
Life-Tech, Inc.
Anesthesiology · 159d
Cleared Dec 22, 2010
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
K102027 · IYO
Quantel Medical S.A.
Radiology · 156d
Cleared Dec 22, 2010
V200 VENTILATOR
K102054 · CBK
Respironics California, Inc.
Anesthesiology · 153d
Cleared Dec 22, 2010
THERMAL MASSAGE BED, MODEL 2D-GX
K102281 · JFB
Inarex Corporation
Physical Medicine · 133d
Cleared Dec 22, 2010
31P/1H DUAL TUNED SURFACE COIL 3T
K102348 · MOS
Rapid Biomedical GmbH
Radiology · 125d
Cleared Dec 22, 2010
PULSE OXIMETER
K102350 · DQA
Nonin Medical, Inc.
Anesthesiology · 125d
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 22, 2010
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · MQV
Globus Medical, Inc.
Orthopedic · 121d
Cleared Dec 22, 2010
GOLIFE NASAL MASK
K102502 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Dec 22, 2010
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
K102565 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Dec 22, 2010
SIMPLYGO BREAST PUMP
K102600 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 103d
Cleared Dec 22, 2010
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
K102605 · NIE
Covidien, LLC, Formerly Registered AS...
Gastroenterology & Urology · 103d
Cleared Dec 22, 2010
NEO-SERVO I
K102710 · FMZ
Atom Medical Corporation
General Hospital · 93d
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Dec 22, 2010
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
K102783 · FRG
Hinson and Hale Medical Technologies,...
General Hospital · 86d
Cleared Dec 22, 2010
MI VARNISH
K102808 · LBH
GC America, Inc.
Dental · 85d
Cleared Dec 22, 2010
LIFEPAK 12
K102972 · MKJ
Physio-Control, Inc.
Cardiovascular · 77d
Cleared Dec 22, 2010
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · HSB
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 22, 2010
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 33d
Cleared Dec 22, 2010
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 22, 2010
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466 · KWS
Arthrex, Inc.
Orthopedic · 28d