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
44113–44136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2012
PURESLEEP
K113022 · LRK
Sleep Science Partners, Inc.
Dental · 244d
Cleared Jun 11, 2012
ARTISYN Y-SHAPED MESH
K113205 · OTO
Ethicon, Inc.
Obstetrics & Gynecology · 224d
Cleared Jun 11, 2012
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION...
K113411 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 206d
Cleared Jun 11, 2012
EPLUS SKIN TREATMENT SYSTEM
K113868 · GEX
Syneron, Ltd.
General & Plastic Surgery · 164d
Cleared Jun 11, 2012
DEPUT DELTA XTEND REVERSE SHOULDER
K120174 · PHX
Depuy France
Orthopedic · 143d
Cleared Jun 11, 2012
STRYKER QUIKFLAP STERILE PROCEDURE PACK
K120352 · GWO
Stryker
Neurology · 126d
Cleared Jun 11, 2012
DISPOSABLE ADHESIVE SURFACE ELECTRODE
K120494 · GXY
Spes Medica Srl
Neurology · 115d
Cleared Jun 11, 2012
REPROCESSED ENDOSCOPIC TROCARS
K121240 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 48d
Cleared Jun 08, 2012
LANO-E
K111604 · LYY
Ug Global Resources Sdn. Bhd.
General Hospital · 366d
Cleared Jun 08, 2012
LANO-E
K111718 · LZA
Ug Global Resources Sdn. Bhd.
General Hospital · 354d
Cleared Jun 08, 2012
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT,...
K112860 · KNT
Coloplast A/S
Gastroenterology & Urology · 252d
Cleared Jun 08, 2012
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K120164 · LIT
Angioslide, Ltd.
Cardiovascular · 141d
Cleared Jun 08, 2012
TBD
K120214 · OOE
Lensar, Inc.
Ophthalmic · 136d
Cleared Jun 08, 2012
VIVA EB
K120334 · CBI
Etview , Ltd.
Anesthesiology · 126d
Cleared Jun 08, 2012
TELIO CS CEM IMPLANT
K120432 · EMA
Ivoclar Vivadent, AG
Dental · 116d
Cleared Jun 08, 2012
EARLYSENSE (EVERON) SYSTEM
K120465 · BZQ
Earlysense, Ltd.
Anesthesiology · 114d
Cleared Jun 08, 2012
MIPAL
K120470 · DRG
Watermark Medical
Cardiovascular · 113d
Cleared Jun 08, 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551 · MUJ
Simuplan S.L.
Radiology · 106d
Cleared Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · DRS
Elcam Medical Acal
Cardiovascular · 99d
Cleared Jun 08, 2012
AERODR STITCHING SYSTEM
K120752 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 88d
Cleared Jun 08, 2012
TUFF-TEMP 2.0
K120784 · EBG
Pulpdent Corporation
Dental · 85d
Cleared Jun 08, 2012
GMK - LINE EXTENSION
K120790 · JWH
Medacta International
Orthopedic · 85d
Cleared Jun 08, 2012
GIRAFFE BLUE SPOT PT LITE
K120820 · LBI
Lumitex, Inc.
General Hospital · 81d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · LIO
Puritan Medical Products, LLC
Microbiology · 80d