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
40873–40896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Jul 03, 2013
NEWTOM VGI AND NEWTOM 5G
K130442 · OAS
Qr S.R.L.
Radiology · 132d
Cleared Jul 03, 2013
ABSOCLEAR
K130553 · FRO
Pharmaplast S.A.E.
General & Plastic Surgery · 121d
Cleared Jul 03, 2013
IFUSION
K130656 · HKI
Optovue, Inc.
Ophthalmic · 113d
Cleared Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · MRC
Menicon Co, Ltd.
Ophthalmic · 100d
Cleared Jul 03, 2013
CYBER TM FAMILY
K131081 · GEX
Quanta System Spa
General & Plastic Surgery · 76d
Cleared Jul 03, 2013
2MP COLOR LCD MONITOR, RADIFORCE MX215
K131090 · LLZ
Eizo Corporation
Radiology · 76d
Cleared Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG...
K131106 · MQB
Canon, Inc.
Radiology · 75d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Arthrex, Inc.
Orthopedic · 42d
Cleared Jul 03, 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · HRS
Emerge Medical
Orthopedic · 42d
Cleared Jul 03, 2013
CP150 ELECTROCARDIOGRAPH
K131573 · DPS
Welch Allyn, Inc.
Cardiovascular · 34d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
K131575 · PHX
Exactech, Inc.
Orthopedic · 33d
Cleared Jul 03, 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · HRS
Biomet, Inc.
Orthopedic · 26d
Cleared Jul 03, 2013
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
K131786 · MWI
Airstrip Technologies, LP
Cardiovascular · 15d
Cleared Jul 02, 2013
ARTHROCARE TURBINATOR WAND
K122652 · GEI
ArthroCare Corporation
General & Plastic Surgery · 305d
Cleared Jul 02, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K123803 · KRD
Reverse Medical Corporation
Cardiovascular · 204d
Cleared Jul 02, 2013
MDK MULTI-APPLICATIONS PLATFORM
K130256 · GEX
Quanta System Spa
General & Plastic Surgery · 151d
Cleared Jul 02, 2013
PROCELLERA
K130350 · FRO
Vomaris Innovations, Inc.
General & Plastic Surgery · 140d
Cleared Jul 02, 2013
SENSUS
K130919 · GZJ
Neurometrix, Inc.
Neurology · 90d
Cleared Jul 02, 2013
CORRECT PLUS 1
K130920 · ELW
Pentron Clinical
Dental · 90d
Cleared Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935 · MQB
Rayence Co., Ltd.
Radiology · 89d
Cleared Jul 02, 2013
VIDA PTV DILATATON CATHETER
K131002 · OMZ
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Jul 02, 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 81d
Cleared Jul 02, 2013
AFFIX SPINOUS PROCESS PLATE SYSTEM
K131238 · PEK
Nuvasive, Inc.
Orthopedic · 62d