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

Filters: Cleared only ×
176,076 results
82993–83016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 31, 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · FRN
Quest Medical, Inc.
General Hospital · 163d
Cleared May 30, 2000
NEOCARE 20 MICRON BLOOD FILTER
K000719 · CAK
Whatman, Inc.
General Hospital · 88d
Cleared May 30, 2000
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR...
K000720 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 88d
Cleared May 30, 2000
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
K001108 · EBF
Prime Dental Manufacturing, Inc.
Dental · 55d
Cleared May 30, 2000
EAGLE ENDO SPECIMEN RETRIEVAL BAG
K001264 · GCJ
Eagle Endoscopic, Inc.
General & Plastic Surgery · 41d
Cleared May 30, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE...
K001302 · GEI
Arthrocare Corp.
General & Plastic Surgery · 36d
Cleared May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · GEI
Aesculap, Inc.
General & Plastic Surgery · 33d