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
39481–39504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2013
VISI MOBILE MONITIORING SYSTEM
K133586 · MWI
Sotera Wireless, Inc.
Cardiovascular · 27d
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 41d
Cleared Dec 17, 2013
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
K130652 · OQG
Consensus Orthopedics, Inc.
Orthopedic · 280d
Cleared Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K130736 · LRC
Helix Medical, LLC
Ear, Nose, Throat · 274d
Cleared Dec 17, 2013
ZOLL EPCR IOS
K131919 · DXJ
ZOLL Medical Corporation
Cardiovascular · 174d
Cleared Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
K132218 · MNH
U&I Corporation
Orthopedic · 153d
Cleared Dec 17, 2013
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264 · HBC
Nakanishi, Inc.
Neurology · 148d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP...
K132340 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Dec 17, 2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K132996 · KXK
Isoray, Inc.
Radiology · 84d
Cleared Dec 17, 2013
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2...
K133079 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared Dec 17, 2013
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+...
K133188 · NKB
Stryker Spine
Orthopedic · 61d
Cleared Dec 17, 2013
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243 · DTK
Rex Medical, L.P.
Cardiovascular · 56d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246 · HRS
Zimmer, Inc.
Orthopedic · 56d
Cleared Dec 17, 2013
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291 · NKB
Zimmer Spine, Inc.
Orthopedic · 53d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342 · JWH
Arthrex, Inc.
Orthopedic · 48d
Cleared Dec 16, 2013
HYALMIX CREAM
K123678 · FRO
Igi Laboratories, Inc.
General & Plastic Surgery · 381d
Cleared Dec 16, 2013
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS,...
K130073 · MNI
Mikron Makina Sanayi VE Ticaret Ltd....
Orthopedic · 339d
Cleared Dec 16, 2013
CLEARGUARD HD END CAP
K131060 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 244d
Cleared Dec 16, 2013
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · GXQ
Synthes, Inc.
Neurology · 181d
Cleared Dec 16, 2013
CORIN METAFIX HIP STEM
K131952 · LZO
Corin USA
Orthopedic · 172d
Cleared Dec 16, 2013
CORIN MINIHIP STEM
K131986 · LZO
Corin USA
Orthopedic · 171d
Cleared Dec 16, 2013
2D PERFUSION
K132147 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Dec 16, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
K132240 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 151d
Cleared Dec 16, 2013
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · DSA
Boston Scientific
Cardiovascular · 150d