FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81865–81888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
STERRAD BI TEST PACK
K993775 · FRC
Advanced Sterilization Products
General Hospital · 206d
Cleared Jun 01, 2000
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
K994116 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 178d
Cleared May 31, 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared May 31, 2000
RELIANCE FAMILY OF WASHER-DISINFECTORS
K983068 · LDS
STERIS Corporation
General Hospital · 637d
Cleared May 31, 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · DXT
Invasatec
Cardiovascular · 553d
Cleared May 31, 2000
SURGEN VALVE
K990331 · FPA
Tiva Medical
General Hospital · 484d
Cleared May 31, 2000
MODIFICATION TO ACIST CL 100H
K991103 · DXT
Acist Medical Systems
Cardiovascular · 426d
Cleared May 31, 2000
RUSCH EMERGENCY MASK
K993528 · CBP
Rusch, Inc.
Anesthesiology · 226d