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
43945–43968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2012
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN...
K120990 · MBH
Zimmer Trabecular Metal Technology
Orthopedic · 88d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · FPA
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jun 29, 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
K121175 · LIT
Ostial Corporation
Cardiovascular · 72d
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d
Cleared Jun 29, 2012
FUSE CAGE
K121288 · MAX
Advanced Medical Technologies AG
Orthopedic · 60d
Cleared Jun 29, 2012
WAVE O CAGE
K121330 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
LOOP CAGE
K121332 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
WAVE D CAGE
K121333 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K121574 · JEY
Synthes, Inc.
Dental · 30d
Cleared Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM...
K121634 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Jun 29, 2012
SYSTEMS INTEGRATION
K121701 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 21d
Cleared Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 582d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Cleared Jun 28, 2012
MED-RX PATIENT DELIVERY SET
K120375 · FPA
Benlan, Inc.
General Hospital · 143d
Cleared Jun 28, 2012
SONY PVM-2551MD OLED MONITOR
K120611 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 120d
Cleared Jun 28, 2012
FIBEROPTIC LASER DELIVERY SYSTEM
K120810 · GEX
Fiberoptic Fabrications, Inc.
General & Plastic Surgery · 104d
Cleared Jun 28, 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · MAX
Nuvasive, Inc.
Orthopedic · 93d
Cleared Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92...
K120996 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared CT Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
K121087 · NBW
Bayer Healthcare
Chemistry · 79d
Cleared Jun 28, 2012
WI-FI BODY SCALE
K121527 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 36d
Cleared Jun 27, 2012
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 286d
Cleared Jun 27, 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · OBR
Oralabs, Inc.
Dental · 230d
Cleared Jun 27, 2012
DATACAPTOR SYSTEM
K113835 · MWI
Capsule Tech, Inc.
Cardiovascular · 183d
Cleared Jun 27, 2012
GAM-200
K120243 · EMA
GC America, Inc.
Dental · 152d