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
82369–82392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · DTB
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · CGA
Selfcare, Inc.
Chemistry · 28d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · JJX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 02, 2000
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 470d
Cleared Jun 02, 2000
XPLORER 1000
K992955 · MQB
Imaging Dynamics Corp.
Radiology · 275d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700 · KXK
Syncor International, Inc.
Radiology · 213d
Cleared Jun 02, 2000
OPTIRAD
K993895 · MUJ
Permedics, Inc.
Radiology · 199d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994069 · ITX
Olympus America, Inc.
Radiology · 183d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994106 · ITX
Olympus America, Inc.
Radiology · 179d
Cleared Jun 02, 2000
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405 · DKE
Alfa Scientific Designs, Inc.
Toxicology · 157d
Cleared Jun 01, 2000
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID...
K000456 · FMF
Harvest Technologies, LLC
General Hospital · 111d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · LYR
Diagnostic Products Corp.
Microbiology · 111d
Cleared Jun 01, 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766 · MNI
Endius, Inc.
Orthopedic · 84d
Cleared Jun 01, 2000
KSEA MANHES PNEUMOTROCAR
K000769 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 84d
Cleared Jun 01, 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · IZH
Instrumentarium Imaging, Inc.
Radiology · 66d
Cleared Jun 01, 2000
VFSS IMAGER, MODEL SIS-300
K000987 · JAA
Lifecare Imaging Intl., Ltd.
Radiology · 66d
Cleared Jun 01, 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
K001004 · JIS
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Jun 01, 2000
WAKO HDL-C/LDL-C CALIBRATOR
K001005 · JIS
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · JJX
Roche Diagnostics Corp.
Immunology · 64d
Cleared Jun 01, 2000
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jun 01, 2000
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
K001209 · MOS
Usa Instruments, Inc.
Radiology · 48d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Hardy Diagnostics
Microbiology · 20d