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
47353–47376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT May 27, 2011
HAIRMAX LASERCOMB
K110233 · OAP
Lexington International, LLC
General & Plastic Surgery · 121d
Cleared May 27, 2011
THE IC-PRO SYSTEM
K110256 · IZI
Paieon, Inc.
Radiology · 119d
Cleared May 27, 2011
ECHOINSIGHT
K110447 · LLZ
Ultrasound Medical Devices, Inc.
Radiology · 100d
Cleared May 27, 2011
CIMARA
K110589 · EBF
Voco GmbH
Dental · 86d
Cleared May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
K110641 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared May 27, 2011
SILJETR SYSTEM
K110642 · EBF
Danville Materials, Inc.
Dental · 81d
Cleared May 27, 2011
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES,...
K110781 · MBI
Arthrocare Corp.
Orthopedic · 67d
Cleared May 27, 2011
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
K110785 · JAA
Toshiba Medical Systems Coporation,...
Radiology · 67d
Cleared May 27, 2011
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
K111098 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 37d
Cleared May 27, 2011
4CH FLEX SPEEDER
K111251 · MOS
Toshiba Medical Systems Coporation,...
Radiology · 23d
Cleared May 27, 2011
GMK REVISION HYBRID LINERS
K111283 · JWH
Medacta International
Orthopedic · 21d
Cleared May 27, 2011
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
K111330 · EHD
Skanray Technologies
Radiology · 16d
Cleared May 26, 2011
CYFRA 21-1 EIA MODEL 211-10
K100831 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 428d
Cleared May 26, 2011
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM...
K101128 · OUK
Filligent Limited
General Hospital · 399d
Cleared May 26, 2011
E3 TORQUE CONTROL MOTOR
K103653 · EBW
Dentsply International, Inc.
Dental · 164d
Cleared May 26, 2011
AFX INTRODUCER SYSTEM
K110090 · DYB
Endologix, Inc.
Cardiovascular · 134d
Cleared May 26, 2011
SURGICAL STIMULATORS
K110422 · ETN
Technomed Europe
Ear, Nose, Throat · 101d
Cleared May 26, 2011
CELL-CHEX WITH CPPD CRYSTALS
K110718 · GLQ
Streck
Hematology · 72d
Cleared May 26, 2011
ATRICURE CRYO MODULE
K111042 · GEH
AtriCure, Inc.
General & Plastic Surgery · 41d
Cleared May 25, 2011
SMART LEISH, MODEL LGM1-050
K081868 · OUZ
U.S. Army Medical Research Institute...
Microbiology · 1057d
Cleared May 25, 2011
RANDOX BARITURATES ASSAY
K092268 · DIS
Randox Laboratories, Ltd.
Toxicology · 666d
Cleared May 25, 2011
GOOD NIGHT
K102463 · LRK
Larry V Connell, Dmd
Dental · 268d
Cleared May 25, 2011
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
K102466 · FET
Fujinon, Inc.
Gastroenterology & Urology · 268d
Cleared May 25, 2011
CLASSIX CHEMICAL STERILIZATION INDICATOR
K102894 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 237d