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
54913–54936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2008
SPECTRA GUIDEWIRE INTRODUCER NEEDLE
K082580 · DYB
Spectra Medical Devices, Inc.
Cardiovascular · 94d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Dec 05, 2008
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K080558 · FRG
Case Medical, Inc.
General Hospital · 281d
Cleared Dec 05, 2008
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
K080595 · JOY
CellaVision AB
Hematology · 277d
Cleared Dec 05, 2008
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
K081073 · OWB
Pausch, LLC
Radiology · 234d
Cleared Dec 05, 2008
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · HHT
Bio Nuclear Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Dec 05, 2008
LUBRICANO STERILE GEL
K081990 · FHX
Farco Pharma GmbH
Gastroenterology & Urology · 144d
Cleared Dec 05, 2008
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
K082001 · JII
Diazyme Laboratories
Toxicology · 144d
Cleared Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
K082049 · LOL
DiaSorin, Inc.
Microbiology · 140d
Cleared Dec 05, 2008
FLEXITIME BITE
K082591 · ELW
Heraeus Kulzer, Inc., Dental Products...
Dental · 88d
Cleared Dec 05, 2008
MRI-PLAQUE VIEW, VERSION 1.1.2003
K082607 · LLZ
Vpdiagnostics, Inc.
Radiology · 88d
Cleared Dec 05, 2008
PRAGER SHELL
K082893 · ITX
Esi, Inc.
Radiology · 66d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913 · LON
Becton, Dickinson & CO
Microbiology · 66d
Cleared Dec 05, 2008
STARBAND
K082950 · OAN
Orthomerica Products, Inc.
Neurology · 63d
Cleared Dec 05, 2008
KODAK 9500
K082972 · MUH
Trophy
Radiology · 60d
Cleared Dec 05, 2008
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
K083029 · IZW
Ralco S.R.L.
Radiology · 56d
Cleared Dec 05, 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL...
K083086 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 50d
Cleared Dec 05, 2008
VIATRONIX V3D-CARDIAC, REVISION 1.0
K083293 · JAK
Viatronix, Inc.
Radiology · 25d
Cleared Dec 04, 2008
ALLOFUSE GEL AND PUTTY
K071849 · MQV
Allosource, Inc.
Orthopedic · 518d
Cleared Dec 04, 2008
MICROWARE BONE PLATES AND BONE SCREWS
K072562 · HRS
Microware Precision Co., Ltd.
Orthopedic · 450d
Cleared Dec 04, 2008
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K080485 · CIT
Diasys Diagnostics Systems GmbH
Chemistry · 286d
Cleared Dec 04, 2008
ZOLL E SERIES WITH INTIBATION ASSIST OPTION
K080903 · MKJ
ZOLL Medical Corporation
Cardiovascular · 247d
Cleared Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 176d
Cleared Dec 04, 2008
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
K081697 · DYB
Access Scientific, Inc.
Cardiovascular · 170d