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
67777–67800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2004
DYRACT CEM PLUS CEMENT
K041272 · EMA
Dentsply Intl.
Dental · 159d
Cleared Oct 18, 2004
CUTERA TABLETOP AESTHETIC PRODUCT
K042165 · ILY
Cutera, Inc.
Physical Medicine · 68d
Cleared Oct 18, 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · GGN
Medtronic Vascular
Hematology · 68d
Cleared Oct 18, 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · GGN
Medtronic Vascular
Hematology · 63d
Cleared Oct 18, 2004
KLS MARTIN DRILL-FREE MMF SCREW
K042573 · DZL
KLS-Martin L.P.
Dental · 27d
Cleared Oct 18, 2004
TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
K042608 · GEI
Tecno Instruments (Pvt.) , Ltd.
General & Plastic Surgery · 24d
Cleared Oct 18, 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627 · FLL
Mesure Technology Co., Ltd.
General Hospital · 21d
Cleared Oct 18, 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · MEA
Hospira, Inc.
General Hospital · 10d
Cleared Oct 15, 2004
LIQUI-HEME GLYCO A1C ASSAY
K031296 · LCP
Biodiagnostic Intl
Chemistry · 541d
Cleared Oct 15, 2004
MODIFICATION TO URETERAL STENT
K040760 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 204d
Cleared Oct 15, 2004
CAP-ONE, MODEL TG-920P
K040875 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 196d
Cleared Oct 15, 2004
INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · DYB
Applied Medical Resources Corp.
Cardiovascular · 130d
Cleared Oct 15, 2004
KELES FACEMASK
K041718 · DZB
Great Lakes Orthodontics, Ltd.
Dental · 113d
Cleared Oct 15, 2004
SILICONE COATED GUIDEWIRE
K041740 · DQX
Arrow International, Inc.
Cardiovascular · 109d
Cleared Oct 15, 2004
INTEGRATED PATIENT MONITORING SYSTEM
K041918 · MWI
Invivo Research, Inc.
Cardiovascular · 91d
Cleared Oct 15, 2004
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · DQD
3M Company
Cardiovascular · 88d
Cleared Oct 15, 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975 · JJY
Maine Standards Co.
Chemistry · 85d
Cleared Oct 15, 2004
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K042306 · DQA
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 51d
Cleared Oct 15, 2004
ENSITE SYSTEM, MODEL EE3000
K042493 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 31d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · DQY
Boston Scientific Corp
Cardiovascular · 24d
Cleared Oct 15, 2004
ACUSON ACUNAV 8F ULTRASOUND CATHETER
K042593 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Oct 15, 2004
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · MEG
Safety Syringes, Inc.
General Hospital · 15d
Cleared Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771 · MSX
Datex-Ohmeda
Cardiovascular · 10d
Cleared Oct 14, 2004
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
K033421 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 353d