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
82681–82704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2000
FRESENIUS 2008K
K994267 · KDI
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287 · LNH
Fonar Corp.
Radiology · 87d
Cleared Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366 · MEH
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Mar 16, 2000
BABY FACE
K994385 · IYO
Sonora Medical Systems
Radiology · 79d
Cleared Mar 16, 2000
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
K994387 · GZJ
Woodside Biomedical, Inc.
Neurology · 79d
Cleared Mar 15, 2000
POSITUBE
K000045 · BTR
Paraproducts, Inc.
Anesthesiology · 68d
Cleared Mar 15, 2000
ACL 9000 SYSTEM
K000053 · JPA
Instrumentation Laboratory CO
Hematology · 68d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 15, 2000
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · KGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 15, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000536 · KWQ
Synthes Spine
Orthopedic · 28d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 15, 2000
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
K990897 · CAF
Puritan-Bennett Ireland, Ltd.
Anesthesiology · 363d
Cleared Mar 15, 2000
IN-LINE HEMOSTASIS VALVE
K990975 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 358d
Cleared Mar 15, 2000
SIGHTSURE OPERATION INDICATOR, MODEL SS301
K993358 · KNT
Medevices, Inc.
Gastroenterology & Urology · 161d
Cleared Mar 15, 2000
DATEX-OHMEDA TONOMETRY MODULE M-TONO
K993656 · CCK
Datex-Ohmeda, Inc.
Anesthesiology · 138d
Cleared Mar 15, 2000
THE HOMMED SENTRY, MODEL 1 SENTRY
K993938 · DXN
Hommed, LLC
Cardiovascular · 117d
Cleared Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 110d
Cleared Mar 15, 2000
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 15, 2000
CENTAUR SPINAL SYSTEM
K994347 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364 · MBI
Synthes (Usa)
Orthopedic · 79d
Cleared Mar 14, 2000
BARCOMED 5MP1H
K000014 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
BARCOMED 5MP2
K000016 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
PARAPOST FIBER WHITE
K000311 · ELR
Coltene/Whaledent, Inc.
Dental · 42d
Cleared Mar 14, 2000
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 28d