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
44737–44760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K111480 · FGB
Technology Delivery Systems, Inc.
Gastroenterology & Urology · 313d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · OMN
Focus Diagnostics, Inc.
Microbiology · 135d
Cleared Apr 04, 2012
EVEREST SPINAL SYSTEM
K120656 · MNI
K2m, Inc.
Orthopedic · 30d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
K120667 · HRS
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 04, 2012
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
K120674 · MPB
Covidien
Gastroenterology & Urology · 30d
Cleared Apr 04, 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · HCG
Codman & Shurtleff, Inc.
Neurology · 29d
Cleared Apr 03, 2012
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB...
K111636 · IOR
Gunnell, Inc.
Physical Medicine · 295d
Cleared Apr 03, 2012
EPICARE YAG
K113115 · GEX
Light Age, Inc.
General & Plastic Surgery · 165d
Cleared Apr 03, 2012
PAGEWRITER TC 20, 30, 50, 70
K113144 · DPS
Philips Medical Systems
Cardiovascular · 161d
Cleared Apr 03, 2012
SECURIS SPINAL FIXATION
K113361 · NKB
Cumtom Spine
Orthopedic · 141d
Cleared Apr 03, 2012
STAPHYLOCOCCUS QUICKFISH BC
K113371 · NXX
Advandx, Inc.
Microbiology · 139d
Cleared Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · LPL
CooperVision, Inc.
Ophthalmic · 104d
Cleared Apr 03, 2012
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
K120065 · JCX
Plaxtron Industrial (M) Sdn. Bhd.
General & Plastic Surgery · 85d
Cleared Apr 03, 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069 · DTL
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Apr 03, 2012
REPROCESSED FEMORAL COMPRESSION DEVICE
K120204 · NMF
Sterilmed, Inc.
Cardiovascular · 71d
Cleared Apr 03, 2012
RTVUE XR OCT
K120238 · HLI
Optovue, Inc.
Ophthalmic · 68d
Cleared Apr 03, 2012
HAMILTON-T1
K120670 · CBK
Hamilton Medical AG
Anesthesiology · 29d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · MAV
Boston Scientific Corp
Cardiovascular · 27d
Cleared Apr 02, 2012
HYBRID GRAFT
K111695 · FTL
Cook Biotech, Inc.
General & Plastic Surgery · 291d
Cleared Apr 02, 2012
A BAER WITH ABAER I/O FUNCTION
K112247 · EWO
Natus Medical Incorporated
Ear, Nose, Throat · 242d
Cleared Apr 02, 2012
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
K112426 · ETN
Xian Friendship Medical Electronics...
Ear, Nose, Throat · 223d
Cleared Apr 02, 2012
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
K112982 · HSB
Small Bone Innovations, Inc.
Orthopedic · 179d
Cleared Apr 02, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K113829 · JWH
Materialise NV
Orthopedic · 97d
Cleared Apr 02, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 70d