FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91273–91296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1998
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
K972701 · LMD
Barco NV Display Systems
Radiology · 168d
Cleared Jan 02, 1998
SPIFE IFE-6
K973040 · CFF
Helena Laboratories
Chemistry · 141d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · GMZ
Shared Systems, Inc.
Microbiology · 112d
Cleared Jan 02, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651 · DIO
OraSure Technologies, Inc.
Toxicology · 99d
Cleared Jan 02, 1998
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K973786 · IWJ
Nw Radiation Therapy Products
Radiology · 88d
Cleared Jan 02, 1998
S-57 VIDEO IMAGING SYSTEM
K973794 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K973795 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-41 &41S VIDEO IMAGING SYSTEM
K973796 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jan 02, 1998
IMAGEACCESS SYSTEM
K973805 · LMD
Storcomm, Inc.
Radiology · 88d
Cleared Jan 02, 1998
FOUNDATION FRACTURE STEM
K973809 · JDI
Encore Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 02, 1998
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
K973863 · DXH
Hi-Tronics Designs, Inc.
Cardiovascular · 85d
Cleared Jan 02, 1998
UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE
K973890 · GEI
Conmedcorp
General & Plastic Surgery · 80d
Cleared Jan 02, 1998
AIMSTICK PBD PREGNANCY
K974368 · DHA
Germaine Laboratories, Inc.
Chemistry · 43d
Cleared Jan 02, 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · JKA
Ohmeda Medical
Chemistry · 43d
Cleared Jan 02, 1998
AIMSTICK PBD COMBO PREGNANCY
K974512 · DHA
Germaine Laboratories, Inc.
Chemistry · 32d
Cleared Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K974620 · JIF
Trace America, Inc.
Chemistry · 22d
Cleared Jan 02, 1998
IMMULITE FREE T3
K974634 · CDP
Diagnostic Products Corp.
Chemistry · 21d
Cleared Dec 31, 1997
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 31, 1997
TEMPERATURE DIAGNOSTIC ACCESSORY
K973764 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Dec 30, 1997
EVERYTIME TRANSFUCER COVER
K955893 · ITX
Amedic AB
Radiology · 746d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663 · GMZ
Murex Biotech , Ltd.
Microbiology · 238d
Cleared Dec 30, 1997
SENTINEL RECORDER, MODELS 471/472
K971696 · DXH
Del Mar Avionics
Cardiovascular · 236d
Cleared Dec 30, 1997
MEDRAD 1.5T EXTREMITY ARRAY
K973787 · MOS
Medrad, Inc.
Radiology · 85d