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
40033–40056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2013
HIGH ENERGY LINEAR ACCELERATOR
K131807 · IYE
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Oct 11, 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 107d
Cleared Oct 11, 2013
MTM(R) CLEAR ALIGNER
K132145 · NXC
Dentsply International, Inc.
Dental · 92d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
K132161 · JWH
Exactech, Inc.
Orthopedic · 91d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Oct 11, 2013
PPA/BT-RB STETHOSCOPE
K132405 · DQD
Rnk Products, Inc.
Cardiovascular · 70d
Cleared Oct 11, 2013
PCP-USB STETHOSCOPE
K132560 · DQD
Rnk Products, Inc.
Cardiovascular · 57d
Cleared Oct 11, 2013
CLASSIC INTERMITTENT CATHETER
K132619 · EZD
Flexicare Medical, Ltd.
Gastroenterology & Urology · 51d
Cleared Oct 11, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132885 · LJS
Cook Incorporated
General Hospital · 25d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · LZO
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Oct 10, 2013
IDYS LIF CAGES
K131178 · MAX
Clariance
Orthopedic · 168d
Cleared Oct 10, 2013
T2 TIBIAL NAILING SYSTEM
K131365 · HSB
Stryker Trauma AG
Orthopedic · 150d
Cleared Oct 10, 2013
PEERSCOPE SYSTEM
K131422 · FDS
Endochoice, Inc.
Gastroenterology & Urology · 147d
Cleared Oct 10, 2013
POLARUS CONNECT
K131636 · LXT
Acumed, LLC
Orthopedic · 128d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · LZO
Biomet, Inc.
Orthopedic · 122d
Cleared Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · LON
bioMerieux, Inc.
Microbiology · 115d
Cleared Oct 10, 2013
3B LASER NEEDLE
K131797 · ILY
Livetec GmbH
Physical Medicine · 114d
Cleared Oct 10, 2013
DELTEX MEDICAL CARDIOQ-EDM+
K132139 · DPW
Deltex Medical Limited
Cardiovascular · 91d
Cleared Oct 10, 2013
IMPLANET SPINE SYSTEM
K132303 · OSH
Implanet, S.A.
Orthopedic · 78d
Cleared Oct 10, 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · MNI
Nexxt Spine, LLC
Orthopedic · 69d
Cleared Oct 10, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K132482 · HCG
Blockade Medical
Neurology · 63d
Cleared Oct 09, 2013
ESOPHAGEAL TTS STENT
K123205 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 362d