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

Filters: Cleared only ×
176,076 results
79681–79704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · MWI
Agilent Technologies, Inc.
Cardiovascular · 17d
Cleared Jun 08, 2001
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX
K011601 · BTA
Ardo Medical AG
General & Plastic Surgery · 15d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · DKZ
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · LAF
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
CARDIOCAM MODEL 9CSY0799
K011611 · KPS
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jun 08, 2001
LIFEJET PRINTER 400
K011617 · LMC
Ferrania S.P.A. Stabilimento DI Ferrania
Radiology · 14d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · JAA
GE Medical Systems
Radiology · 14d
Cleared Jun 07, 2001
XSCAN32 TELERADIOLOGY SOFTWARE
K002911 · LLZ
Radiographic Digital Imaging, Inc.
Radiology · 262d
Cleared Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
K010455 · KFF
Diagnostica-Stago
Hematology · 129d
Cleared Jun 07, 2001
SOLA 700,SOLA 500, SOLA 300
K010724 · FTD
Drager Medizintechnik GmbH
General & Plastic Surgery · 87d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · FYA
Standard Textile Co., Inc.
General Hospital · 83d
Cleared Jun 07, 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN...
K010862 · KGO
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Jun 07, 2001
HYCARE LATEX EXAMINATION GLOVE, POWDERED
K010875 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 76d
Cleared Jun 07, 2001
UNI-LASER 470
K010885 · GEX
Medart Corp.
General & Plastic Surgery · 76d
Cleared Jun 07, 2001
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K011001 · LWM
Satelec
Dental · 90d
Cleared Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · JIH
Dade Behring, Inc.
Chemistry · 63d
Cleared Jun 07, 2001
PARADIGM QUICK-SET INFUSION SET
K011071 · FPA
Maersk Medical A/S
General Hospital · 59d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE...
K011370 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER...
K011371 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT...
K011377 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 06, 2001
PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
K001917 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 348d
Cleared Jun 06, 2001
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
K002410 · IPF
Dysphagia, LLC
Physical Medicine · 303d
Cleared Jun 06, 2001
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846 · BTM
Headstar Medical Products Co., Ltd.
Anesthesiology · 267d