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
54721–54744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · LFX
bioMerieux, Inc.
Microbiology · 280d
Cleared Dec 23, 2008
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · HET
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 243d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 187d
Cleared Dec 23, 2008
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K081768 · NAJ
Cook Incorporated
Obstetrics & Gynecology · 186d
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · LKT
Diagnostic Hybrids, Inc.
Microbiology · 169d
Cleared Dec 23, 2008
BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
K081971 · LZC
Nitritex (M) Sdn. Bhd.
General Hospital · 166d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 99d
Cleared Dec 23, 2008
SUBCUTANEOUS NEEDLE INFUSION SET
K082818 · FPA
Marcal Medical, Inc.
General Hospital · 89d
Cleared Dec 23, 2008
RSVP HALF SPHERE PHANTOM, MODEL DDP010
K082909 · IYE
The Phantom Laboratory, Inc.
Radiology · 84d
Cleared Dec 23, 2008
TORNADO ROTATABEL SNARE AND POLYP CATCHER
K083049 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 70d
Cleared Dec 23, 2008
QUICKIE RHYTHM
K083249 · ITI
Sunrise Medical Hhg, Inc.
Physical Medicine · 49d
Cleared Dec 23, 2008
HELIODENT PLUS
K083344 · EHD
Sirona Dental Systems GmbH
Radiology · 40d
Cleared Dec 23, 2008
IMAGE-ARENA APPLICATIONS
K083348 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 40d
Cleared Dec 23, 2008
TT1 GENERAL PURPOSE COIL
K083434 · MOS
Tursiop Technologies, LLC
Radiology · 33d
Cleared Dec 23, 2008
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474 · NHA
Zimmer Dental, Inc.
Dental · 29d
Cleared Dec 23, 2008
MISER CONTRAST MANAGEMENT SYSTEM
K083576 · FPA
Merit Medical Systems, Inc.
General Hospital · 20d
Cleared Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · GEX
Quanta System Spa
General & Plastic Surgery · 15d
Cleared Dec 23, 2008
FIXATION TROCARS
K083638 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 14d
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN...
K081008 · DJG
Lin-Zhi International, Inc.
Toxicology · 256d
Cleared Dec 22, 2008
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
K081148 · IYO
Siemens Medical Solutions USA, Inc.,...
Radiology · 244d
Cleared Dec 22, 2008
CRANIAL PERFORATOR
K082637 · HBF
The Anspach Effort, Inc.
Neurology · 103d
Cleared Dec 22, 2008
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K082651 · DZE
Southern Implants, Inc.
Dental · 101d
Cleared Dec 22, 2008
PHANTOM PLUS CAGE SYSTEM
K082801 · ODP
Us Spine
Orthopedic · 89d
Cleared Dec 22, 2008
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
K082829 · OLF
Carleton Life Support Systems, Inc.
Anesthesiology · 88d