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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53929–53952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2009
OKAMOTO ULTRA THIN
K090259 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 31, 2009
AUTOSPECT
K090403 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 42d
Cleared Mar 31, 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 34d
Cleared Mar 31, 2009
LIFEDOP MODEL, L350R
K090499 · MAA
Summit Doppler Systems, Inc.
Radiology · 34d
Cleared Mar 31, 2009
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
K090553 · KPS
Naviscan, Inc.
Radiology · 29d
Cleared Mar 31, 2009
VITABLOCS, MODEL VX55-****
K090644 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 21d
Cleared Mar 31, 2009
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · BTY
Shape Medical Systems, Inc.
Anesthesiology · 12d
Cleared Mar 30, 2009
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 369d
Cleared Mar 30, 2009
SENTINEL, MODEL SP-001
K082582 · IYE
C-Rad Positioning AB
Radiology · 203d
Cleared Mar 30, 2009
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P,...
K082719 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 194d
Cleared Mar 30, 2009
EPTFE SLFTM SPIRAL VASCULAR GRAFT
K083169 · DSY
Tayside Flow Technologies Limited
Cardiovascular · 154d
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT,...
K083487 · NRP
Siemens Healthcare Diagnostics
Toxicology · 125d
Cleared Mar 30, 2009
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL...
K083784 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Mar 30, 2009
THE WAND MICROACCESS SAFETY INTRODUCER
K090372 · DYB
Access Scientific, Inc.
Cardiovascular · 45d
Cleared Mar 27, 2009
ONEPLANT DENTAL IMPLANT SYSTEM
K081748 · DZE
Warantec Co., Ltd.
Dental · 281d
Cleared Mar 27, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · FRG
Kimberly-Clark Corp.
General Hospital · 238d
Cleared Mar 27, 2009
HYLATOPIC EMOLLIENT FOAM
K083024 · MGQ
Collegium Pharmaceutical Incorporated
General & Plastic Surgery · 169d
Cleared Mar 27, 2009
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
K083161 · HRX
Conmed Linvatec
Orthopedic · 151d
Cleared Mar 27, 2009
GORE BIO-A FISTULA PLUG
K083266 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 142d
Cleared Mar 27, 2009
SYNTHASOME X-REPAIR
K083307 · FTL
Synthasome, Inc.
General & Plastic Surgery · 137d
Cleared Mar 27, 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863 · MNI
Theken Spine, LLC
Orthopedic · 88d
Cleared Mar 27, 2009
BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII...
K083869 · DZE
Btlock Srl
Dental · 88d
Cleared Mar 27, 2009
SPI VARIOMULTI ANGLED ABUTMENT
K090153 · NHA
Thommen Medical AG
Dental · 64d
Cleared Mar 27, 2009
UA-CELLULAR FOR IQ
K090201 · JPK
Streck
Hematology · 59d