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
62761–62784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2006
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
K060240 · FLL
K-Jump Health Co., Ltd.
General Hospital · 108d
Cleared May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
K060478 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared May 19, 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 19, 2006
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
K060704 · PHX
Zimmer, Inc.
Orthopedic · 64d
Cleared May 19, 2006
MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
K060827 · IYN
Esaote, S.P.A.
Radiology · 53d
Cleared May 19, 2006
TURKOM-CERA
K060860 · EIH
Dental Suppliers of America, Inc.
Dental · 51d
Cleared May 19, 2006
TRIPOD
K060926 · IOR
Freedom Designs, Inc.
Physical Medicine · 45d
Cleared May 19, 2006
XIA TITANIUM AND 4.5 SPINAL SYSTEMS
K060979 · NKB
Stryker Spine
Orthopedic · 39d
Cleared May 19, 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · HRS
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared May 19, 2006
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
K061078 · LYY
Bright Element Sdn Bhd
General Hospital · 32d
Cleared May 19, 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared May 18, 2006
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
K053193 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 184d
Cleared May 18, 2006
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502 · MLM
Dade Behring, Inc.
Toxicology · 83d
Cleared May 18, 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
K060503 · DLJ
Dade Behring, Inc.
Toxicology · 83d
Cleared May 18, 2006
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
K060821 · LPL
Specialeyes, LLC
Ophthalmic · 52d
Cleared May 18, 2006
3MATIC
K060950 · LLZ
Materialise NV
Radiology · 42d
Cleared May 18, 2006
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS...
K061063 · MCW
Foxhollow Technologies, Inc.
Cardiovascular · 31d
Cleared May 18, 2006
ENPATH MEDICAL STEERABLE SHEATH
K061119 · DQY
Enpath Medical, Inc.
Cardiovascular · 27d
Cleared May 18, 2006
TRABECTOME HIGH FREQUENCY GENERATOR/LP
K061258 · GEI
Neomedix Corp.
General & Plastic Surgery · 13d
Cleared May 18, 2006
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
K061259 · GEI
Arthrocare Corp.
General & Plastic Surgery · 13d
Cleared May 18, 2006
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
K061260 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 13d
Cleared May 17, 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
K050032 · FRO
Euromed, Inc.
General & Plastic Surgery · 495d
Cleared May 17, 2006
MIDIVIEW SERIES OF MICROENDOSCOPES
K051073 · GCJ
Millennium Devices, Inc.
General & Plastic Surgery · 386d
Cleared May 17, 2006
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
K052691 · JOW
Suretek Medical
Cardiovascular · 231d